Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-01-04 @ 2:03 PM
Study NCT ID:
NCT02168257
Status:
TERMINATED
Last Update Posted:
2017-07-21
First Post:
2014-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}], 'ancestors': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-06-19', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pulse', 'timeFrame': '3 hrs'}, {'measure': 'Respiratory Rate', 'timeFrame': '3 hrs'}, {'measure': 'Blood Pressure', 'timeFrame': '3 hrs'}, {'measure': 'Oxygen requirement', 'timeFrame': '3 hrs', 'description': 'Measured by fraction of inspired oxygen to maintain target pulse oximetry saturation.'}], 'primaryOutcomes': [{'measure': 'Oxygenation', 'timeFrame': '3 hrs', 'description': 'Pulse oximetry'}, {'measure': 'Ventilation', 'timeFrame': '3 hrs', 'description': 'transcutaneous carbon dioxide monitor'}], 'secondaryOutcomes': [{'measure': 'Esophageal pressure measurements', 'timeFrame': '3 hrs', 'description': 'Esophageal Pressure Catheter'}, {'measure': 'Apnea', 'timeFrame': '3 hrs', 'description': '3-channel pneumogram'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nasal Cannula'], 'conditions': ['Respiratory Distress Syndrome, Newborn', 'Continuous Positive Airway Pressure', 'Low Birth Weight Infants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low Birth Weight Infant\n* Currently on continuous positive aireway pressure of 5-7 cm water pressure\n* Receiving continuous positive airway pressure support for \\> 24 hrs prior to enrollment\n* Fraction of inspired oxygen requirement of 23-50%\n\nExclusion Criteria:\n\n* Fraction of inspired oxygen \\> 50%\n* Congenital defects of head, pulmonary or cardiovascular systems\n* Chromosomal abnormalities/genetic syndromes\n* Invasive Surgical Procedure within 24 hrs prior to enrollment\n* Enrollment in separate clinical trial that has ongoing data collection'}, 'identificationModule': {'nctId': 'NCT02168257', 'briefTitle': 'Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospitals and Clinics of Minnesota"}, 'officialTitle': 'Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates', 'orgStudyIdInfo': {'id': '1303-032'}, 'secondaryIdInfos': [{'id': '47575', 'type': 'OTHER_GRANT', 'domain': "Children's Hospitals and Clinics of Minnesota IRGP"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RAM Cannula CPAP', 'description': 'CPAP provided by RAM Cannula', 'interventionNames': ['Device: RAM Cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Binasal Prong CPAP', 'description': 'CPAP provided by binasal prong', 'interventionNames': ['Device: Binasal Prong CPAP']}], 'interventions': [{'name': 'RAM Cannula', 'type': 'DEVICE', 'armGroupLabels': ['RAM Cannula CPAP']}, {'name': 'Binasal Prong CPAP', 'type': 'DEVICE', 'armGroupLabels': ['Binasal Prong CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Neil P Mulrooney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospitals and Clinics of Minnesota"}, {'name': 'Andrea L Lampland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospitals and Clinics of Minnesota"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospitals and Clinics of Minnesota", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}