Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-17 @ 11:06 PM
Study NCT ID:
NCT04264156
Status:
TERMINATED
Last Update Posted:
2023-05-24
First Post:
2020-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
Sponsor:
Organization:
Raw JSON
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The publication or presentation of any study results shall comply with all applicable privacy laws, including but not limited to HIPAA.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was terminated early leading to a very small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.', 'eventGroups': [{'id': 'EG000', 'title': 'Lucinactant (160 mg/kg) + nCPAP', 'description': 'Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth\n\nLucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'nCPAP Only', 'description': 'nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time\n\nnCPAP Only: Nasal CPAP Alone', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Coagulation disorder neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Congenital pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Duodenal atresia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Necrotizing enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastric residual assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Feeding intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Agitation neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bradycardia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Intraventricular haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Jaundice neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Infantile apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neonatal aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasal septum ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neonatal tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Umbilical erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haemostatsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Poor peripheral circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Duodenal atresia', 'notes': 'Worsening congenital partial duodenal artesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Respiratory Failure or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant (160 mg/kg) + nCPAP', 'description': 'Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth\n\nLucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.'}, {'id': 'OG001', 'title': 'nCPAP Only', 'description': 'nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time\n\nnCPAP Only: Nasal CPAP Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days of life', 'description': 'Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number With BPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant (160 mg/kg) + nCPAP', 'description': 'Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol once, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth\n\nLucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.'}, {'id': 'OG001', 'title': 'nCPAP Only', 'description': 'nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time\n\nnCPAP Only: Nasal CPAP Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 weeks post-menstrual age (PMA)', 'description': 'Number of participants with bronchopulmonary dysplasia (BPD)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant (160 mg/kg) + nCPAP', 'description': 'Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth\n\nLucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.'}, {'id': 'OG001', 'title': 'nCPAP Only', 'description': 'nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time\n\nnCPAP Only: Nasal CPAP Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 weeks PMA or 28 days of life (whichever is later)', 'description': 'All-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Common Complications of Prematurity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant (160 mg/kg) + nCPAP', 'description': 'Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth\n\nLucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.'}, {'id': 'OG001', 'title': 'nCPAP Only', 'description': 'nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time\n\nnCPAP Only: Nasal CPAP Alone'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 weeks PMA', 'description': 'Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lucinactant (160 mg/kg) + nCPAP', 'description': 'Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth\n\nLucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.'}, {'id': 'FG001', 'title': 'nCPAP Only', 'description': 'nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time\n\nnCPAP Only: Nasal CPAP Alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment period: 18 April 2020 to 19 January 2021 Enrollment occurred in neonatal intensive care units.', 'preAssignmentDetails': 'Subjects were screened before enrollment. Screen fail reasons included: unable to maintain required FiO2 (majority of screen fails), no determination of RDS, need for mechanical ventilation, outside of enrollment window'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lucinactant (160 mg/kg) + nCPAP', 'description': 'Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth\n\nLucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.'}, {'id': 'BG001', 'title': 'nCPAP Only', 'description': 'nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time\n\nnCPAP Only: Nasal CPAP Alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.25', 'groupId': 'BG000', 'lowerLimit': '1.05', 'upperLimit': '4.85'}, {'value': '1.05', 'groupId': 'BG001', 'lowerLimit': '1.05', 'upperLimit': '1.05'}, {'value': '3.02', 'groupId': 'BG002', 'lowerLimit': '1.05', 'upperLimit': '4.85'}]}]}], 'paramType': 'MEDIAN', 'description': 'Subjects are newborns', 'unitOfMeasure': 'hours', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Gestational Age', 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'BG000', 'lowerLimit': '28.4', 'upperLimit': '32.6'}, {'value': '31.0', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '31'}, {'value': '30.4', 'groupId': 'BG002', 'lowerLimit': '29.1', 'upperLimit': '31.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Gestational Age (GA) in weeks', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Poland', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Apgar Score at One Minute', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '7.0', 'groupId': 'BG001', 'lowerLimit': '7', 'upperLimit': '7'}, {'value': '7.0', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Apgar score measures appearance, pulse, grimace, activity, and respiration. Scores range from 0 to 10 (0 to 2 for each component with 2 being the best). A score of 7-10 is considered "reassuring." Measured at 1 or 5 minutes after birth for this study.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Apgar Score at Five Minutes', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '8'}, {'value': '8.0', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '8'}, {'value': '8.0', 'groupId': 'BG002', 'lowerLimit': '7', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'description': 'Apgar score measures appearance, pulse, grimace, activity, and respiration. Scores range from 0 to 10 (0 to 2 for each component with 2 being the best). A score of 7-10 is considered "reassuring." Measured at 1 or 5 minutes after birth for this study.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Intent-to-Treat'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-09', 'size': 2122030, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-01T17:18', 'hasProtocol': True}, {'date': '2021-08-01', 'size': 616873, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-01T17:12', 'hasProtocol': False}, {'date': '2019-08-09', 'size': 242506, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-01T17:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The first 2 subjects at each site for each cohort will be dosed with open-label active treatment for training purposes. Following the first 2 subjects, preparation and delivery of treatment will be blinded from the study staff. Treatment will be delivered behind a partition and no information about treatment will be given to investigator, parents, or other applicable study staff.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a multinational, multicenter, double-blind (masked), parallel group, randomized, controlled study, in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Corporate business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2020-02-07', 'resultsFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-27', 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Respiratory Failure or Death', 'timeFrame': '28 days of life', 'description': 'Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration'}], 'secondaryOutcomes': [{'measure': 'Number With BPD', 'timeFrame': '36 weeks post-menstrual age (PMA)', 'description': 'Number of participants with bronchopulmonary dysplasia (BPD)'}, {'measure': 'Mortality', 'timeFrame': '36 weeks PMA or 28 days of life (whichever is later)', 'description': 'All-cause mortality'}, {'measure': 'Number of Participants With Common Complications of Prematurity', 'timeFrame': '36 weeks PMA', 'description': 'Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['intubation', 'surfactant', 'continuous positive airway pressure', 'aerosol', 'respiratory distress syndrome'], 'conditions': ['Respiratory Distress Syndrome, Newborn']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure and/or death due to RDS in the first 72 hours and 28 days of life. Half of the subjects will receive lucinactant for inhalation and half will receive standard of care (nCPAP alone).', 'detailedDescription': 'An unmet medical need exists for a means to deliver surfactant replacement therapy (SRT) to preterm neonates with RDS supported with nCPAP early in the course of the disease. This strategy has the potential to improve RDS prior to the development of respiratory failure, thereby avoiding the need for endotracheal intubation and mechanical ventilation (MV), or reduce the duration of MV, and the resultant potential for morbidity and complications. The ability to administer SRT via aerosol has the potential to address this unmet need.\n\nLucinactant for inhalation (AEROSURF) is an investigational drug-device combination product, designed to deliver aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP. The drug component of lucinactant for inhalation is lyophilized lucinactant, a lyophilized form of SURFAXIN® (lucinactant) Intratracheal Suspension. The device component, the AEROSURF Delivery System (ADS), the next-generation device following use of the prototype device in earlier trials, uses novel technology to aerosolize lucinactant for inhalation.\n\nThis study evaluates the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by pre-specified outcome measures. In addition, this study will evaluate the device and the ability to administer up to 3 repeat doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'minimumAge': '30 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed ICF from legally authorized representative.\n* Gestational age: 26 to 32+6 weeks PMA.\n* Successful implementation of non-invasive support or ventilation within 30 minutes after birth.\n* Spontaneous breathing.\n* Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis.\n* Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 \\> 0.25 to ≤ 0.35 to maintain SpO2 of 90% to 95%.\n\nExclusion Criteria:\n\n* A heart rate that cannot be stabilized above 100 bpm within 5 minutes of birth.\n* Recurrent episodes of apnea requiring positive pressure ventilation.\n* A 5 minute Apgar score \\< 5.\n* Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP.\n* Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function.\n* A known or suspected chromosomal abnormality or syndrome.\n* Premature rupture of membranes \\> 3 weeks.\n* Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis.\n* A need for intubation and/or invasive mechanical ventilation at any time before enrollment into the study.\n* The administration (or plan for administration) of another investigational agent or investigational medical device, any other surfactant agent, or systemic corticosteroids.\n* Presence of air leak on the baseline chest radiograph or diagnosed via ultrasound or illumination.'}, 'identificationModule': {'nctId': 'NCT04264156', 'briefTitle': 'A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm 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 Versus nCPAP Alone in Preterm Neonates 26 to 32 Weeks Gestational Age With RDS', 'orgStudyIdInfo': {'id': '03-CL-1702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lucinactant (160 mg/kg) + nCPAP', 'description': 'Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol once, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth', 'interventionNames': ['Combination Product: Lucinactant for Inhalation']}, {'type': 'SHAM_COMPARATOR', 'label': 'nCPAP Only', 'description': 'nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time', 'interventionNames': ['Other: nCPAP Only']}], 'interventions': [{'name': 'Lucinactant for Inhalation', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['AEROSURF'], 'description': 'A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nasal continuous positive airway pressure (nCPAP).', 'armGroupLabels': ['Lucinactant (160 mg/kg) + nCPAP']}, {'name': 'nCPAP Only', 'type': 'OTHER', 'description': 'Nasal continuous positive airway pressure (nCPAP) alone', 'armGroupLabels': ['nCPAP Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-902', 'city': 'Bytom', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny nr 2 w Bytomiu Oddzial Noworodkow Blok Va', 'geoPoint': {'lat': 50.34802, 'lon': 18.93282}}, {'zip': '60-535', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Ginekologiczno-Polozniczy Szpital Kliniczny Uniwewersytetu Medycznego im. Karola Marcinkowskiego', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '70-780', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Spcjalistyczny Zaklad Opieki Zdrowotnej "Zdroje", Oddzial Noworodkow', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}], 'overallOfficials': [{'name': 'Carlos Guardia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Windtree Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Windtree Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}