Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-25 @ 10:36 PM
Study NCT ID:
NCT02636868
Status:
COMPLETED
Last Update Posted:
2021-04-23
First Post:
2015-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
Sponsor:
Organization:
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'psimmons@windtreetx.com', 'phone': '215-488-9477', 'title': 'Executive Director of Biostatistics & Data Management', 'organization': 'Windtree Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'The Steering Committee is responsible for publications, including who will be authoring publications. The sponsor has the right to review publications before they are published and can provide suggested edits, but cannot require changes or prevent publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Clogging of a in-line filter led to a higher number of treatment interruptions than expected. This primarily affected one batch of supplies that were, by chance, predominantly used in European sites.'}}, 'adverseEventsModule': {'timeFrame': 'Enrollment to 36 weeks post-menstrual age', 'eventGroups': [{'id': 'EG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 65, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 69, 'seriousNumAtRisk': 72, 'deathsNumAffected': 1, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'nCPAP Only', 'description': 'nCPAP alone\n\nnCPAP: Nasal CPAP', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 66, 'seriousNumAtRisk': 71, 'deathsNumAffected': 2, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Anaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 37, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 52, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coagulation disorder neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Necrotising enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Feeding intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypermagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Agitation neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bradycardia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intraventricular haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Jaundice neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 47, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 50, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 46, 'numAffected': 41}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retinopathy of prematurity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decrease neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Apnoea neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atelectasis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchopulmonaria dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neonatal tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coarctation of the aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Necrotising enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neurological infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nocosomial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Septic embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 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{'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via 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'populationDescription': 'Modified Intent-to-Treat; randomized subjects who received study treatment'}, {'type': 'SECONDARY', 'title': 'Incidence of Respiratory Failure or Death Due to RDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria 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'pValueComment': 'a priori threshold of statistical significance set at 0.05', 'groupDescription': 'Null hypothesis is no difference across treatment groups', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model'}, {'pValue': '0.648', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'a priori threshold of statistical significance set at 0.05', 'groupDescription': 'Null hypothesis is no difference across treatment groups', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'description': 'Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population without Treatment Interruptions'}, {'type': 'SECONDARY', 'title': 'Time to nCPAP Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG002', 'title': 'nCPAP Only', 'description': 'nCPAP alone\n\nnCPAP: Nasal CPAP'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '44.8', 'spread': '2.69', 'groupId': 'OG001'}, {'value': '40.7', 'spread': '2.44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.996', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'a priori threshold of statistical significance set at 0.05', 'groupDescription': 'Null hypothesis of no difference across treatments', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.951', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'a priori threshold of statistical significance set at 0.05', 'groupDescription': 'Null hypothesis of no difference between treatments', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.995', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'a priori threshold of statistical significance set at 0.05', 'groupDescription': 'Null hypothesis of no difference between treatments', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '72 hours', 'description': 'Time from birth to nCPAP Failure', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat; randomized participants who received study treatment'}, {'type': 'SECONDARY', 'title': 'Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG002', 'title': 'nCPAP Only', 'description': 'nCPAP alone\n\nnCPAP: Nasal CPAP'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.312', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'A priori threshold of statistical significance set at 0.10', 'groupDescription': 'Null hypothesis of no difference between treatment groups', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model'}, {'pValue': '0.094', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'A priori threshold of statistical significance set at 0.10', 'groupDescription': 'Null hypothesis of no difference between treatment groups', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model'}, {'pValue': '0.414', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'A priori threshold of statistical significance set at 0.10', 'groupDescription': 'Null hypothesis of no difference between treatment groups', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'description': 'The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Incidence of Respiratory Failure or Death Due to RDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG002', 'title': 'nCPAP Only', 'description': 'nCPAP alone\n\nnCPAP: Nasal CPAP'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.099', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'A priori statistical significance of 0.05', 'groupDescription': 'Null hypothesis of no difference between treatment groups', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO2) in model'}, {'pValue': '0.090', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'A priori statistical significance of 0.05', 'groupDescription': 'Null hypothesis of no difference between treatments', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pooled site, treatment, gender, birth weight, and baseline FiO2 in model'}, {'pValue': '0.461', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'A priori statistical significance of 0.05', 'groupDescription': 'Null hypothesis of no difference between treatment groups', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pooled site, treatment, gender, birth weight, and baseline FiO2 in model'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bronchopulmonary Dysplasia (BPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'OG002', 'title': 'nCPAP Only', 'description': 'nCPAP alone\n\nnCPAP: Nasal CPAP'}], 'classes': [{'title': 'BPD', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Alive without BPD', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.534', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'A priori threshold for statistical significance set at 0.05', 'groupDescription': 'Null hypothesis of no treatment between treatments', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'treatment and pooled site in model'}, {'pValue': '0.480', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'A priori threshold for statistical significance set at 0.05', 'groupDescription': 'Null hypothesis of no difference between treatment groups', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment and pooled site in model'}, {'pValue': '0.313', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'A priori threshold for statistical significance set at 0.05', 'groupDescription': 'Null hypothesis of no difference between treatment groups', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment and pooled site in model'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 weeks post-menstrual age (PMA)', 'description': 'Summarizes the number of participants with BPD or alive without BPD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'FG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'FG002', 'title': 'nCPAP Only', 'description': 'nCPAP alone\n\nnCPAP: Nasal CPAP'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aerosolized Lucinactant (40 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'BG001', 'title': 'Aerosolized Lucinactant (80 mg TPL/kg)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.\n\nLucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)\n\nnCPAP: Nasal CPAP'}, {'id': 'BG002', 'title': 'nCPAP Only', 'description': 'nCPAP alone\n\nnCPAP: Nasal CPAP'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Gestational Age', 'categories': [{'measurements': [{'value': '30.8', 'spread': '1.24', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '1.17', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '1.17', 'groupId': 'BG002'}, {'value': '30.7', 'spread': '1.19', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks post menstrual age', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Birth Weight', 'classes': [{'categories': [{'measurements': [{'value': '1557.0', 'spread': '342.38', 'groupId': 'BG000'}, {'value': '1505.8', 'spread': '378.5', 'groupId': 'BG001'}, {'value': '1446.4', 'spread': '359.13', 'groupId': 'BG002'}, {'value': '1503.4', 'spread': '361.73', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ruptured Membranes', 'classes': [{'title': 'Spontaneous', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'Artificial', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chorioamnionitis', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Steroid Use, Maternal', 'classes': [{'title': 'Used Steroids', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}]}, {'title': 'No Steroids', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mode of Delivery', 'classes': [{'title': 'Vaginal', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': 'Cesarean Section', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth Status', 'classes': [{'title': 'Single Birth', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}]}, {'title': 'Multiple Birth', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Appearance, Pulse, Grimace, Activity, and Respiration (Apgar) Score at One Minute', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '1.74', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '1.71', 'groupId': 'BG001'}, {'value': '6.8', 'spread': '1.61', 'groupId': 'BG002'}, {'value': '6.6', 'spread': '1.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "In the test, five things are used to check a baby's health at 1 minutes after birth. Each is scored on a scale of 0 to 2, with 2 being the best score:\n\nAppearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort) The individual scores are summed to determine the total score.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apgar Score at Five Minutes', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '0.90', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '1.02', 'groupId': 'BG001'}, {'value': '8.1', 'spread': '1.00', 'groupId': 'BG002'}, {'value': '8.1', 'spread': '0.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "In the test, five things are used to check a baby's health at 5 minutes after birth. Each is scored on a scale of 0 to 2, with 2 being the best score:\n\nAppearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort) The individual scores are summed to determine the total score.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Congenital Anomaly', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Randomized Participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-19', 'size': 2008438, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-07T12:59', 'hasProtocol': True}, {'date': '2017-04-27', 'size': 813568, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-07T12:55', 'hasProtocol': False}, {'date': '2016-02-25', 'size': 679768, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-07T13:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2015-11-19', 'resultsFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2015-12-17', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-30', 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)', 'timeFrame': '72 hours', 'description': 'Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure'}], 'secondaryOutcomes': [{'measure': 'Incidence of Respiratory Failure or Death Due to RDS', 'timeFrame': '72 hours', 'description': 'Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria'}, {'measure': 'Time to nCPAP Failure', 'timeFrame': '72 hours', 'description': 'Time from birth to nCPAP Failure'}, {'measure': 'Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling', 'timeFrame': '72 hours', 'description': 'The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred.'}, {'measure': 'Incidence of Respiratory Failure or Death Due to RDS', 'timeFrame': '28 days', 'description': 'Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria'}, {'measure': 'Number of Participants With Bronchopulmonary Dysplasia (BPD)', 'timeFrame': '36 weeks post-menstrual age (PMA)', 'description': 'Summarizes the number of participants with BPD or alive without BPD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.', 'detailedDescription': 'The purpose of this study is to investigate the safety and efficacy of lucinactant for inhalation in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA). Efficacy and safety are based on clinical evaluations. The endpoints specified are similar to those in Protocols 03-CL-1201 and 03-CL-1401 to allow for potential comparison and pooling of results.\n\nThe objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, compared to nCPAP alone, in preterm neonates with RDS, as assessed by the time to and incidence of respiratory failure and/or death due to RDS over the first 72 hours of life, the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks PMA, and change in physiologic parameters (FiO2 and PCO2) over the first 72 hours of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '26 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent form (ICF) from legally authorized representative\n2. 26 0/7 to 32 6/7 completed weeks gestation PMA\n3. Successful implementation of non-invasive support or ventilation within 90 minutes after birth\n4. Spontaneous breathing\n5. Chest radiograph consistent with RDS\n6. Within the first 20 hours after birth requires an nCPAP of 5 to 7 centimeters water (cmH2O) with a fraction of inspired oxygen (FiO2) of ≥ 0.25 (\\>0.21 for neonates 26-28 weeks PMA) to 0.40 that is clinically indicated for at least 30 minutes to maintain oxygen by pulse oximetry (SpO2) of 90% to 95%. Transient (\\<10 minutes) FiO2 excursions outside this range do not reset the 30-minute requirement.\n\nExclusion Criteria:\n\n1. A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5 minutes of birth\n2. Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface\n3. A 5 minute Apgar score \\< 5\n4. Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth\n5. Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (e.g. congenital heart disease, hydrops fetalis or congenital infection)\n6. A known or suspected chromosomal abnormality or syndrome\n7. Premature rupture of membranes (PROM) \\> 3 weeks\n8. Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis\n9. A need for intubation and/or mechanical ventilation at any time before enrollment into the study\n10. The administration (or plan for administration) of any the following:\n\n * Another investigational agent or investigational medical device\n * Any other surfactant agent\n * Systemic corticosteroids (other than antenatal steroids already received)\n11. Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema (PIE)) on the baseline chest radiograph'}, 'identificationModule': {'nctId': 'NCT02636868', 'briefTitle': 'The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Windtree Therapeutics'}, 'officialTitle': 'A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess The Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age With Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '03-CL-1202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerosolized lucinactant (low dose)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.', 'interventionNames': ['Drug: Lucinactant delivered via investigational delivery device', 'Drug: nCPAP']}, {'type': 'EXPERIMENTAL', 'label': 'Aerosolized lucinactant (high dose)', 'description': 'Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.', 'interventionNames': ['Drug: Lucinactant delivered via investigational delivery device', 'Drug: nCPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nasal CPAP', 'description': 'nCPAP alone', 'interventionNames': ['Drug: nCPAP']}], 'interventions': [{'name': 'Lucinactant delivered via investigational delivery device', 'type': 'DRUG', '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': ['Aerosolized lucinactant (high dose)', 'Aerosolized lucinactant (low dose)']}, {'name': 'nCPAP', 'type': 'DRUG', 'description': 'Nasal CPAP', 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