Viewing Study NCT02528318

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Ignite Creation Date: 2025-12-25 @ 4:52 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
Study NCT ID: NCT02528318
Status: TERMINATED
Last Update Posted: 2019-07-23
First Post: 2015-08-17
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502722', 'term': 'lucinactant'}, {'id': 'D001239', 'term': 'Inhalation'}, {'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rsegal@windtreetx.com', 'phone': '215-488-9300', 'title': 'Robert Segal, MD, FACP', 'phoneExt': '9450', 'organization': 'Windtree Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'The preparation and submittal for publication of a manuscript containing the study results shall be in accordance with a process determined by a mutual written agreement among Windtree Therapeutics, Inc. and participating institutions. The publication or presentation of any study results shall comply with all applicable privacy laws, including, but not limited to, HIPAA.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated prior to subject enrollment for the 150 mg TPL/kg dose by the sponsor for administrative reasons.\n\nThe overall results may have been impacted by treatment interruptions caused by clogging of study drug.'}}, 'adverseEventsModule': {'timeFrame': 'From randomization to 36 weeks PMA', 'description': 'This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.', 'eventGroups': [{'id': 'EG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Bandaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Cardiac septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Gastric hypomotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Gastrointestinal hypomotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Salivary hypersection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Endotracheal intubation complication', 'notes': 'Inadvertent extubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 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{'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Shock', 'notes': 'Refractory shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Peri-Dosing Adverse Events - Initial Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Desaturation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Gagging/regurgitation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Apnea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pallor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 24 Hours Post Randomization', 'description': 'Number of Participants with adverse events that were experienced during the initial study treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Peri-dosing events are events that occur during study treatment. Since this was an open-label study, no peri-dosing events were recorded for nCPAP alone. Any adverse events that occurred during the corresponding time for nCPAP alone were recorded as adverse events but not peri-dosing events.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Air Leak', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worsening of Respiratory Status Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 72 Hours Post Randomization', 'description': 'Number of participants with worsening in one of 12 respiratory status criteria through 72 hours post randomization (need for additional surfactant therapy, desaturation \\< 80%, heart rate \\< 100 bpm, sustained fraction of inspired oxygen (FiO2) \\> 0.50, arterial carbon dioxide (PCO2) \\> 65 mmHg, sustained apnea, persistent arterial pH \\< 7.2, intubation for any reason, nCPAP \\> 7 cmH2O, initiation of intermittent positive pressure ventilation, death, principal investigator determination of worsening status)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Bronchopulmonary Dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'title': 'BPD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Alive and Without BPD', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': 'Number of participants with bronchopulmonary dysplasia (BPD) and number of participants alive and without BPD at 36 weeks post-menstrual age (PMA)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 72 Hours Post Randomization', 'description': 'Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': 'Number of participants who died during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'FiO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'title': 'Baseline (Randomization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.071', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.072', 'groupId': 'OG002'}, {'value': '0.32', 'spread': '0.061', 'groupId': 'OG004'}]}]}, {'title': '60 Minutes Post Randomization - Observed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.063', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '0.34', 'spread': '0.159', 'groupId': 'OG004'}]}]}, {'title': '60 Minutes Post Randomizati - Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.010', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.044', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.162', 'groupId': 'OG004'}]}]}, {'title': '3 Hours Post Randomization - Observed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.120', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '0.29', 'spread': '0.082', 'groupId': 'OG004'}]}]}, {'title': '3 Hours Post Randomizaiton - Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.154', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.066', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.047', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.082', 'groupId': 'OG004'}]}]}, {'title': '12 Hours Post Randomization - Observed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.114', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.117', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.068', 'groupId': 'OG002'}, {'value': '0.33', 'spread': '0.181', 'groupId': 'OG004'}]}]}, {'title': '12 Hours Post Randomization - Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.074', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.172', 'groupId': 'OG004'}]}]}, {'title': '24 Hours Post Randomized - Observed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.044', 'groupId': 'OG001'}, {'value': '0.28', 'spread': '0.077', 'groupId': 'OG002'}, {'value': '0.29', 'spread': '0.143', 'groupId': 'OG004'}]}]}, {'title': '24 Hours Post Randomized - Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.046', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '-0.04', 'spread': '0.140', 'groupId': 'OG004'}]}]}, {'title': '48 Hours Post Randomized - Observed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.071', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '0.188', 'groupId': 'OG004'}]}]}, {'title': '48 Hours Post Randomized - Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.075', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.091', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '0.191', 'groupId': 'OG004'}]}]}, {'title': '72 Hours Post Randomized - Observed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.050', 'groupId': 'OG002'}, {'value': '0.27', 'spread': '0.119', 'groupId': 'OG004'}]}]}, {'title': '72 Hours Post Randomized - Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.071', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.066', 'groupId': 'OG002'}, {'value': '-0.05', 'spread': '0.133', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 72 hours post randomization', 'description': 'Observed and change from baseline measurements for fraction of inspired oxygen (FiO2). Values represent the amount (fraction) of oxygen in the air the participant inspires; the values themselves do not have units. The normal amount of oxygen in air ("room air") is 21%, or 0.21.', 'unitOfMeasure': 'Fraction of oxygen in inspired air', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complications of Prematurity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'title': 'Subjects with Any Complication', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG004'}]}]}, {'title': 'Acquired Sepsis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Apnea', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG004'}]}]}, {'title': 'Cystic Periventricular Leukomalcia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Patent Ductus Arteriosus', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Pulmonary Hemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Intraventicular Hemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Necrotizing Enterocolitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Retinopathy of Prematurity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': 'Number of participants with pre-specified common complications of prematurity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'nCPAP Failure Without Treatment Interruptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'OG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 72 Hours Post Randomization', 'description': 'Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Without Treatment Interruption'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg total phospholipids (TPL)/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'FG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'FG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'FG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'FG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'comment': 'Study was terminated prior to initiation of this intervention', 'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'BG001', 'title': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'BG002', 'title': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'BG003', 'title': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.\n\nLucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)'}, {'id': 'BG004', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone\n\nnCPAP alone: nCPAP therapy'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': 'Gestational Age', 'categories': [{'measurements': [{'value': '27.6', 'spread': '0.61', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '1.06', 'groupId': 'BG001'}, {'value': '27.2', 'spread': '0.84', 'groupId': 'BG002'}, {'value': '27.5', 'spread': '0.76', 'groupId': 'BG004'}, {'value': '27.4', 'spread': '0.84', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': "Gestational age, based on obstetrician's best estimate", 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Birth Weight', 'classes': [{'categories': [{'measurements': [{'value': '1052', 'spread': '174.7', 'groupId': 'BG000'}, {'value': '855', 'spread': '84.6', 'groupId': 'BG001'}, {'value': '839', 'spread': '224.9', 'groupId': 'BG002'}, {'value': '1005', 'spread': '238.8', 'groupId': 'BG004'}, {'value': '960', 'spread': '209.4', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apgar Score at One Minute', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '9'}, {'value': '5.5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '6.4', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '8'}, {'value': '5.8', 'groupId': 'BG004', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '5.8', 'groupId': 'BG005', 'lowerLimit': '1', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'description': "The Apgar Score measures a baby's health by assessing five characteristics (Appearance, Pulse, Grimace, Activity, and Respiration) . Each of the five characteristics are scored from 0 to 2, and the five scores are summed for the Apgar Score. Thus, the Apgar Score ranges from 0 (worst) to 10 (best), and scores over 7 indicate a baby in good health. Apgar Scores are performed at 1 minute and 5 minutes after birth.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Apgar Score at Five Minutes', 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '9'}, {'value': '6.4', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '8.1', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '9'}, {'value': '7.9', 'groupId': 'BG004', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '7.7', 'groupId': 'BG005', 'lowerLimit': '1', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'description': "The Apgar Score measures a baby's health by assessing five characteristics (Appearance, Pulse, Grimace, Activity, and Respiration) . Each of the five characteristics are scored from 0 to 2, and the five scores are summed for the Apgar Score. Thus, the Apgar Score ranges from 0 (worst) to 10 (best), and scores over 7 indicate a baby in good health. Apgar Scores are performed at 1 minute and 5 minutes after birth.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-13', 'size': 777368, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-26T12:04', 'hasProtocol': False}, {'date': '2015-09-02', 'size': 1632122, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-26T12:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'Sponsor decision to terminate after 3 dosing groups', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2015-08-17', 'resultsFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2015-08-17', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-17', 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'nCPAP Failure Without Treatment Interruptions', 'timeFrame': 'Randomization to 72 Hours Post Randomization', 'description': 'Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Peri-Dosing Adverse Events - Initial Dose', 'timeFrame': 'Randomization to 24 Hours Post Randomization', 'description': 'Number of Participants with adverse events that were experienced during the initial study treatment'}, {'measure': 'Number of Participants With Air Leak', 'timeFrame': '7 days', 'description': 'Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Worsening of Respiratory Status Criteria', 'timeFrame': 'Randomization to 72 Hours Post Randomization', 'description': 'Number of participants with worsening in one of 12 respiratory status criteria through 72 hours post randomization (need for additional surfactant therapy, desaturation \\< 80%, heart rate \\< 100 bpm, sustained fraction of inspired oxygen (FiO2) \\> 0.50, arterial carbon dioxide (PCO2) \\> 65 mmHg, sustained apnea, persistent arterial pH \\< 7.2, intubation for any reason, nCPAP \\> 7 cmH2O, initiation of intermittent positive pressure ventilation, death, principal investigator determination of worsening status)'}, {'measure': 'Bronchopulmonary Dysplasia', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': 'Number of participants with bronchopulmonary dysplasia (BPD) and number of participants alive and without BPD at 36 weeks post-menstrual age (PMA)'}, {'measure': 'Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure', 'timeFrame': 'Randomization to 72 Hours Post Randomization', 'description': 'Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP'}, {'measure': 'Death', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': 'Number of participants who died during the study'}, {'measure': 'FiO2', 'timeFrame': 'Randomization to 72 hours post randomization', 'description': 'Observed and change from baseline measurements for fraction of inspired oxygen (FiO2). Values represent the amount (fraction) of oxygen in the air the participant inspires; the values themselves do not have units. The normal amount of oxygen in air ("room air") is 21%, or 0.21.'}, {'measure': 'Number of Participants With Complications of Prematurity', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': 'Number of participants with pre-specified common complications of prematurity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.', 'detailedDescription': 'This study was a multicenter, randomized, controlled, open-label, dose-escalation study, conducted to evaluate the safety and tolerability of lucinactant for inhalation in conjunction with nasal continuous positive airway pressure (nCPAP) in comparison with nCPAP alone. The study was to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in 4 escalating doses.\n\nFor this study, lucinactant for inhalation refers to the active investigational agent, lyophilized lucinactant, in combination with the prototype investigational delivery device. Reconstituted lyophilized lucinactant was aerosolized by the investigational device and introduced into the nCPAP circuit. Those randomized to the control arm continued to receive nCPAP alone. Dose assignments were unblinded, as the primary objective of this study was safety and tolerability.\n\nPreterm neonates with respiratory distress syndrome (RDS) between 26 and 28 completed weeks PMA who were within the first 20 hours after birth and who had successful implementation of controlled nCPAP within 90 minutes of birth were considered to be potential subjects. Before study enrollment, legal guardians were provided a written informed consent form (ICF) for each potential subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Weeks', 'minimumAge': '26 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent from a legally authorized representative.\n2. Gestational age 26 to 28 completed weeks post menstrual age (PMA).\n3. Successful implementation of controlled nCPAP within 90 minutes after birth.\n4. Spontaneous breathing.\n5. Chest radiograph consistent with RDS.\n6. Within the first 20 hours after birth, have an nCPAP of 5 to 6 cm H2O to maintain oxygen saturation measured by pulse oximetry (SpO2) of 88% to 95% with a fraction of inspired oxygen (FiO2) of 0.25 to 0.50 that is clinically indicated for at least 30 minutes. Transient (\\<10 minutes) FiO2 excursions below 0.25 or above 0.50 did not reset the 30 minute requirement.\n\nExclusion Criteria:\n\n1. Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth.\n2. Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface.\n3. A 5 minute Apgar score \\< 5.\n4. Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth.\n5. Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH).\n6. Known or suspected chromosomal abnormality or syndrome.\n7. Premature rupture of membranes (PROM) \\> 2 weeks.\n8. Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis.\n9. Need for endotracheal intubation and mechanical ventilation.\n10. Has been administered: another investigational agent or investigational medical device, any other surfactant agent, steroid treatment after birth.'}, 'identificationModule': {'nctId': 'NCT02528318', 'briefTitle': 'Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Windtree Therapeutics'}, 'officialTitle': 'A Multicenter, Randomized, Open-label, Controlled Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA', 'orgStudyIdInfo': {'id': '03-CL-1401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 mg/kg', 'description': 'Lucinactant for inhalation 50 mg total phospholipids (TPL)/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.', 'interventionNames': ['Combination Product: Lucinactant for inhalation']}, {'type': 'EXPERIMENTAL', 'label': '75 mg/kg', 'description': 'Lucinactant for inhalation 75 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.', 'interventionNames': ['Combination Product: Lucinactant for inhalation']}, {'type': 'EXPERIMENTAL', 'label': '100 mg/kg', 'description': 'Lucinactant for inhalation 100 mg TPL/kg with nCPAP\n\n1 repeat dose allowed if repeat dosing criteria are met.', 'interventionNames': ['Combination Product: Lucinactant for inhalation']}, {'type': 'EXPERIMENTAL', 'label': '150 mg/kg', 'description': 'Lucinactant for inhalation 150 mg TPL/kg with nCPAP\n\n1 repeat dose will be allowed if repeat dosing criteria are met.', 'interventionNames': ['Combination Product: Lucinactant for inhalation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nCPAP alone', 'description': 'nCPAP therapy alone', 'interventionNames': ['Device: nCPAP alone']}], 'interventions': [{'name': 'Lucinactant for inhalation', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['AEROSURF®'], 'description': 'Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)', 'armGroupLabels': ['100 mg/kg', '150 mg/kg', '50 mg/kg', '75 mg/kg']}, {'name': 'nCPAP alone', 'type': 'DEVICE', 'otherNames': ['nasal continuous positive airway pressure'], 'description': 'nCPAP therapy', 'armGroupLabels': ['nCPAP alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mary Birch Hospital for Women and Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Columbia University College of Physicians and Surgeons, New York Presbyterian Hospital - Morgan Stanley Children's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'New Hanover Regional Medical Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women and Infants Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandria Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Montreal Children's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '8207257', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Dr Sotero Del Rio', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8350488', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital San Juan de Dios', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '60-535', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'state': 'Kujawsko-pomorksie', 'country': 'Poland', 'facility': 'S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '00-315', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '93-338', 'city': 'Lodz', 'state': 'Łódź Voivodeship', 'country': 'Poland', 'facility': 'Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Steve Simonson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Windtree Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Windtree Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}