Viewing Study NCT03058666

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Ignite Creation Date: 2025-12-24 @ 4:02 PM
Ignite Modification Date: 2026-02-24 @ 12:25 AM
Study NCT ID: NCT03058666
Status: COMPLETED
Last Update Posted: 2024-05-29
First Post: 2017-02-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117342', 'term': 'calfactant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jcummings@onybiotech.com', 'phone': '7166369096', 'title': 'James Cummings, MD', 'organization': 'Ony Biotech'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Birth to 28 days or discharge, whichever came first.', 'eventGroups': [{'id': 'EG000', 'title': 'Aerosolized Calfactant', 'description': 'Aerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.\n\nSolarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.', 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 225, 'seriousNumAtRisk': 241, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'There will be no protocol driven interventions in the usual care group.', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 219, 'seriousNumAtRisk': 236, 'deathsNumAffected': 1, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 53, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 54, 'numAffected': 54}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Polycythemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 195, 'numAffected': 195}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 191, 'numAffected': 191}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Retinopathy of prematurity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Feeding Intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Necrotizing enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Unspecified nutritional deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alkaline phosphatase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypochloremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 116, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 108, 'numAffected': 108}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intraventricular hemorrhage grade I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intraventricular hemorrhage grade II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchopulmonary dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypoxemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary interstitial emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Respiratory insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tachypnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diaper Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypovolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Air Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 23, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 23, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Spontaneous intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Necrotizing enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Intraventricular hemorrhage, Grade IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Periventricular leukomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchopulmonary dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Primary pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pink colored oral discharge secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intubation and Instillation of Liquid Surfactant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Calfactant', 'description': '1. NICU Patients with a clinical diagnosis of RDS\n2. Inspired oxygen ≥21% to maintain adequate oxygen saturation\n3. Not Intubated\n4. Requiring Nasal continuous positive airway pressure\n\nAerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.\n\nSolarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'There will be no protocol driven interventions in the usual care group.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours', 'description': 'Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients.'}, {'type': 'SECONDARY', 'title': 'Respiratory Support Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Calfactant', 'description': 'Aerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.\n\nSolarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'There will be no protocol driven interventions in the usual care group.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Difference of Respiratory support at 28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Air Leak', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerosolized Calfactant', 'description': 'Aerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.\n\nSolarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'There will be no protocol driven interventions in the usual care group.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Percent of at risk subjects with air leak at any time', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aerosolized Calfactant', 'description': '1. NICU Patients with a clinical diagnosis of RDS\n2. Inspired oxygen ≥21% to maintain adequate oxygen saturation\n3. Not Intubated\n4. Requiring Nasal continuous positive airway pressure\n\nAerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.\n\nSolarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'There will be no protocol driven interventions in the usual care group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '236'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '236'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aerosolized Calfactant', 'description': '1. NICU Patients with a clinical diagnosis of RDS\n2. Inspired oxygen ≥21% to maintain adequate oxygen saturation\n3. Not Intubated\n4. Requiring Nasal continuous positive airway pressure\n\nAerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.\n\nSolarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'There will be no protocol driven interventions in the usual care group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.2', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '33.1', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '477 were randomized into the two cohorts between April 2017 and June 2018. Having reached our sample size target for cohort 1, further enrollment into cohort 2 was discontinued.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-25', 'size': 1219031, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-06T11:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 477}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2017-02-16', 'resultsFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-01', 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation and Instillation of Liquid Surfactant', 'timeFrame': '72 hours', 'description': 'Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.'}], 'secondaryOutcomes': [{'measure': 'Respiratory Support Requirements', 'timeFrame': '28 days', 'description': 'Difference of Respiratory support at 28 days'}, {'measure': 'Air Leak', 'timeFrame': '28 days', 'description': 'Percent of at risk subjects with air leak at any time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Aerosol', 'surfactant', 'calfactant', 'Infasurf', 'Respiratory Distress Syndrome', 'RDS', 'Premature', 'Neonates'], 'conditions': ['Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '33060258', 'type': 'DERIVED', 'citation': 'Cummings JJ, Gerday E, Minton S, Katheria A, Albert G, Flores-Torres J, Famuyide M, Lampland A, Guthrie S, Kuehn D, Weitkamp JH, Fort P, Abu Jawdeh EG, Ryan RM, Martin GC, Swanson JR, Mulrooney N, Eyal F, Gerstmann D, Kumar P, Wilding GE, Egan EA; AERO-02 STUDY INVESTIGATORS. Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial. Pediatrics. 2020 Nov;146(5):e20193967. doi: 10.1542/peds.2019-3967. Epub 2020 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.', 'detailedDescription': 'Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRDS Patients\n\n1. NICU patient, ≥1hour of age and \\<24 hours of age.\n2. Clinical diagnosis of RDS, with or without chest X-ray data.\n3. Inspired oxygen ≥21% to maintain adequate oxygen saturation.\n4. Not intubated\n5. Requiring:\n\n 1. nasal continuous positive airway pressure (nCPAP).\n\nExclusion Criteria:\n\n1. Congenital anomaly limiting care options or requiring early surgery.\n2. Cardiopulmonary decompensation.\n\n 1. hypotension with metabolic acidosis (base excess \\< -10 meq/l).\n 2. Oxygen saturations \\< 88% at start of aerosolization.\n 3. PaCO2 ≥ 60 mmHg at start of aerosolization.\n3. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.\n4. Acute hypoxic encephalopathy with or without seizures.'}, 'identificationModule': {'nctId': 'NCT03058666', 'briefTitle': 'Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ONY'}, 'officialTitle': 'Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients', 'orgStudyIdInfo': {'id': 'Aero-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerosolized Calfactant', 'description': '1. NICU Patients with a clinical diagnosis of RDS\n2. Inspired oxygen ≥21% to maintain adequate oxygen saturation\n3. Not Intubated\n4. Requiring Nasal continuous positive airway pressure', 'interventionNames': ['Drug: Aerosolized Calfactant', 'Device: Solarys']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'There will be no protocol driven interventions in the usual care group.'}], 'interventions': [{'name': 'Aerosolized Calfactant', 'type': 'DRUG', 'otherNames': ['Infasurf', 'Calfactant'], 'description': 'Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.', 'armGroupLabels': ['Aerosolized Calfactant']}, {'name': 'Solarys', 'type': 'DEVICE', 'description': 'Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.', 'armGroupLabels': ['Aerosolized Calfactant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': "USA Children's & Women's Hospital", 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner - University Medical Center Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mary Birch Hospital for Women & Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Adventist Healthcare System, Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "Johns Hopkins All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida, Tampa general', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Columbus Regional Hospital', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF Saint Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': "Kentucky Children's Hospital, University of Kentucky Medical Center", 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospital and Clinics", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospital Minnesota", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Sisters of Charity Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27835', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pitt County Memorial Hospital', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'The Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Jackson-Madison County General Hospital', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt university Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'North central Baptist Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'Timpanogos Regional Medical Center', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}, {'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Valley Hospital', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virgina Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'James Cummings, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Albany Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ONY', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}