Viewing Study NCT04545866

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Ignite Creation Date: 2025-12-24 @ 4:21 PM
Ignite Modification Date: 2025-12-27 @ 2:35 PM
Study NCT ID: NCT04545866
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-11-10
First Post: 2020-09-04
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: The Budesonide in Babies (BiB) Trial
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': '2025-09-24', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D019819', 'term': 'Budesonide'}, {'id': 'D013501', 'term': 'Surface-Active Agents'}, {'id': 'C068291', 'term': 'poractant alfa'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nambalav@uabmc.edu', 'phone': '2059344680', 'title': 'Namasivayam Ambalavanan MD', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.', 'description': 'AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment.\n\nAll-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer).\n\nNote: Treatment group is reported as randomized. Published analyses may use treatment as received.', 'eventGroups': [{'id': 'EG000', 'title': 'BUDE', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg', 'otherNumAtRisk': 323, 'deathsNumAtRisk': 323, 'otherNumAffected': 232, 'seriousNumAtRisk': 323, 'deathsNumAffected': 49, 'seriousNumAffected': 63}, {'id': 'EG001', 'title': 'SURF', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg', 'otherNumAtRisk': 318, 'deathsNumAtRisk': 318, 'otherNumAffected': 187, 'seriousNumAtRisk': 318, 'deathsNumAffected': 42, 'seriousNumAffected': 55}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Newborn persistent pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Necrotising colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Necrotising enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hyperammonaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 263, 'numAffected': 208}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 191, 'numAffected': 154}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Intraventricular haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Periventricular leukomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary air leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary interstitial emphysema syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 31, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 45, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 57, 'numAffected': 53}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}], 'seriousEvents': [{'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cardio-respiratory arrest neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Newborn persistent pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary hypoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Necrotising colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Neonatal intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Intraventricular haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Intraventricular haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Neonatal asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Neonatal pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary air leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Pulmonary hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 318, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}], 'frequencyThreshold': '0.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physiologic BPD or Death by 36 Weeks PMA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BUDE', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'OG001', 'title': 'SURF', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': "A composite outcome for infants who were diagnosed with physiologic BPD or died by 36 weeks PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. Infants alive an in hospital are classified based on respiratory status at 36 week's PMA or by a room air weaning challenge performed between 36 and 37 weeks' PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks' PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks' PMA.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.'}, {'type': 'SECONDARY', 'title': 'Death by 36 Weeks PMA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BUDE', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'OG001', 'title': 'SURF', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '272', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': 'Died (all-cause) after randomization and by 36 weeks PMA', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.'}, {'type': 'SECONDARY', 'title': 'Physiologic BPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BUDE', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'OG001', 'title': 'SURF', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 36 weeks PMA', 'description': "Diagnosed with physiologic BPD at 36 weeks PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. Infants alive an in hospital are classified based on respiratory status at 36 week's PMA or by a room air weaning challenge performed between 36 and 37 weeks' PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks' PMA are not assessed for BPD.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.'}, {'type': 'SECONDARY', 'title': 'Grade of BPD Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BUDE', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'OG001', 'title': 'SURF', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}], 'classes': [{'categories': [{'title': 'Grade 0 (No BPD)', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Grade 1 (Mild BPD)', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}, {'title': 'Grade 2 (Moderate BPD)', 'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}, {'title': 'Grade 3 (Severe BPD)', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 36 weeks PMA', 'description': "BPD Severity Grade at 36 weeks PMA according to the Jensen et al. (2019; PMID: 30995069) definition, also known as pragmatic BPD. Infants are assess based on the mode of support at 36 weeks' postmenstrual age regardless of prior duration or current level of oxygen therapy.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.'}, {'type': 'SECONDARY', 'title': 'Severe BPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BUDE', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'OG001', 'title': 'SURF', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 36 weeks PMA', 'description': 'Diagnosed with Severe (Grade 3) BPD at 36 weeks PMA according to the Jensen et al. (2019; PMID: 30995069) definition. This outcome is a dichotomy of the pragmatic BPD severity grades (Grade 3 vs. Grade 2, 1, or 0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.'}, {'type': 'SECONDARY', 'title': 'Use of Additional Postnatal Steroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BUDE', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'OG001', 'title': 'SURF', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '216', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post last dose of study drug through 36 weeks PMA', 'description': 'Use of any postnatal steroids for treatment of evolving chronic lung disease (separate from study drug) between 7 days after the final dose of study drug and 36 weeks PMA.\n\nNote: Infants were permitted up to two doses of study drug within 50 hours postnatal age, so this outcome spans 7-10 days postnatal age through 36 weeks postmenstrual age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Budesonide + Surfactant', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'FG001', 'title': 'Surfactant Alone', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '323'}, {'groupId': 'FG001', 'numSubjects': '318'}]}, {'type': 'COMPLETED', 'comment': 'Completed Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '321'}, {'groupId': 'FG001', 'numSubjects': '318'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Parent(s)/Legal Guardian(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Physician', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "One infant was randomized and treated in error after the parent/guardian declined consent. The infant was withdrawn from the trial upon discovery of the protocol violation. At the parent's request, the infant's data have been fully redacted. No data are available for reporting or analysis (including treatment allocation), and this participant is excluded from the intention to treat (ITT) population."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '641', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BUDE', 'description': 'Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'BG001', 'title': 'SURF', 'description': 'Surfactant (poractant alfa; Curosurf) 2.5 ml/kg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '2', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'Greater Than or Equal to 26 0/7 weeks', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}, {'title': 'Less Than 26 0/7 weeks', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Black or African America', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '508', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-08', 'size': 428816, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-18T10:04', 'hasProtocol': True}, {'date': '2024-09-10', 'size': 2606722, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-18T10:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator, primary providers, primary data collectors, and participants will be masked to randomization arm assignment. Only research pharmacists and a designated respiratory therapist (or other qualified person) will be unmasked at the enrolling sites. The designated respiratory therapist (or other qualified person) must be unmasked to allow drug mixing at bedside for expeditious study drug administration; however, this person will not be the primary medical provider nor the primary data collector for that infant, and will not be otherwise involved in the research.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 642}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2020-09-04', 'resultsFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-28', 'studyFirstPostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiologic BPD or Death by 36 Weeks PMA', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': "A composite outcome for infants who were diagnosed with physiologic BPD or died by 36 weeks PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. Infants alive an in hospital are classified based on respiratory status at 36 week's PMA or by a room air weaning challenge performed between 36 and 37 weeks' PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks' PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks' PMA."}], 'secondaryOutcomes': [{'measure': 'Death by 36 Weeks PMA', 'timeFrame': 'Randomization to 36 weeks PMA', 'description': 'Died (all-cause) after randomization and by 36 weeks PMA'}, {'measure': 'Physiologic BPD', 'timeFrame': 'At 36 weeks PMA', 'description': "Diagnosed with physiologic BPD at 36 weeks PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. Infants alive an in hospital are classified based on respiratory status at 36 week's PMA or by a room air weaning challenge performed between 36 and 37 weeks' PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks' PMA are not assessed for BPD."}, {'measure': 'Grade of BPD Severity', 'timeFrame': 'At 36 weeks PMA', 'description': "BPD Severity Grade at 36 weeks PMA according to the Jensen et al. (2019; PMID: 30995069) definition, also known as pragmatic BPD. Infants are assess based on the mode of support at 36 weeks' postmenstrual age regardless of prior duration or current level of oxygen therapy."}, {'measure': 'Severe BPD', 'timeFrame': 'At 36 weeks PMA', 'description': 'Diagnosed with Severe (Grade 3) BPD at 36 weeks PMA according to the Jensen et al. (2019; PMID: 30995069) definition. This outcome is a dichotomy of the pragmatic BPD severity grades (Grade 3 vs. Grade 2, 1, or 0).'}, {'measure': 'Use of Additional Postnatal Steroids', 'timeFrame': '7 days post last dose of study drug through 36 weeks PMA', 'description': 'Use of any postnatal steroids for treatment of evolving chronic lung disease (separate from study drug) between 7 days after the final dose of study drug and 36 weeks PMA.\n\nNote: Infants were permitted up to two doses of study drug within 50 hours postnatal age, so this outcome spans 7-10 days postnatal age through 36 weeks postmenstrual age.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchopulmonary Dysplasia (BPD)', 'Respiratory Distress Syndrome', 'Prematurity; Extreme', 'Neonatal']}, 'referencesModule': {'references': [{'pmid': '41026481', 'type': 'DERIVED', 'citation': "Ambalavanan N, Carlo WA, Nowak KJ, Wiener LE, Cosby SS, Bhatt AJ, Watterberg KL, Poindexter BB, Keszler M, D'Angio CT, Brion LP, Narendran V, Rau CA, Cotten CM, Laughon MM, Das A, Rysavy MA, Hibbs AM, Fuller J, Puopolo KM, Katheria A, Patel RM, Bermick JR, Laptook AR, Prelipcean I, Wyckoff MH, Moore R, Merhar SL, Ohls RK, Yoder BA, Perez M, Ghavam S, Meyer LR, Chock VY, DeMauro SB, Jackson WM, Handa D, Walsh MC; National Institute of Child Health and Human Development Neonatal Research Network. Early Intratracheal Budesonide to Reduce Bronchopulmonary Dysplasia in Extremely Preterm Infants: The Budesonide in Babies (BiB) Randomized Clinical Trial. JAMA. 2025 Oct 28;334(16):1452-1462. doi: 10.1001/jama.2025.16450."}]}, 'descriptionModule': {'briefSummary': "This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will reduce the incidence of physiologic bronchopulmonary dysplasia (BPD) or death by 36 weeks' post-menstrual age in extremely preterm infants.", 'detailedDescription': "From a study of 9575 extremely preterm (22-28 weeks gestational age and 401-1500g birth weight) infants born between 2003 and 2007 and enrolled in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN), it is anticipated that 93% of extremely preterm infants will develop respiratory distress syndrome, 68% will develop bronchopulmonary dysplasia (BPD), 16% will develop severe intraventricular hemorrhage, and 36% will develop late-onset sepsis (PMID: 20732945). Furthermore, in 2014 20% of the infants enrolled in the NRN Generic Database (GDB) died (8% by less than 12 hours, 12% between 12 hours and 120 days, and 1% after 120 days) and 47% of infants who survived to 36 weeks' post-menstrual age (PMA) developed physiologic BPD (NRN GDB data). BPD is therefore one of the most common morbidities in extremely preterm infants. Death is a competing outcome for BPD, as infants who die before ascertainment of BPD at 36 weeks' PMA cannot be diagnosed with BPD even though they may have been at the highest risk. As children get older, BPD has been shown to be associated with worse cognitive outcomes in school age and with abnormal pulmonary function in adolescence and adulthood (PMID: 14595077; 15499947; 2247118).\n\nRecent randomized trials have indicated a lower incidence of BPD/death with the use of a combination of budesonide with surfactant (budesonide + surfactant) compared to surfactant alone when administered soon after birth. Therefore, after obtaining informed consent and confirming eligibility for the trial, infants are randomized in a 1:1 allocation ratio to either the budesonide + surfactant arm or the surfactant alone arm within 48 hours of birth."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liveborn infants 22 0/7 - 28 6/7 weeks gestation or 401 - 1000 grams (inclusive) birth weight\n* Clinical decision to give surfactant\n* Less than or equal to 48 hours postnatal age\n\nExclusion Criteria:\n\n* Terminal illness (heart rate \\< 100 beats per minute, unresponsiveness to resuscitation) or unlikely to survive as judged by the clinician\n* Decision to redirect or limit support\n* Use of surfactant before enrollment (first dose of surfactant must be study drug)\n* Infant received systemic steroids prior to enrollment\n* Use of indomethacin, either received by the mother within 24 hours prior to delivery,received by the infant prior to enrollment, or intent to administer to the infant for IVH prophylaxis or PDA management from enrollment up to 7 days of final dose of study drug\n* Serious chromosomal abnormalities or major malformations\n* Known congenital infections including, but not limited to, confirmed sepsis, congenital CMV, etc.\n* Infants with a permanent neuromuscular condition that affects respiration\n* Enrollment in a conflicting clinical trial'}, 'identificationModule': {'nctId': 'NCT04545866', 'acronym': 'BiB', 'briefTitle': 'The Budesonide in Babies (BiB) Trial', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Neonatal Research Network'}, 'officialTitle': 'Randomized Controlled Trial of Budesonide + Surfactant Versus Surfactant Alone in Extremely Preterm Infants ("The Budesonide in Babies (BiB) Trial")', 'orgStudyIdInfo': {'id': 'NICHD-NRN-0064'}, 'secondaryIdInfos': [{'id': 'UG1HD034216', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD034216', 'type': 'NIH'}, {'id': 'UG1HD027904', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD027904', 'type': 'NIH'}, {'id': 'UG1HD021364', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD021364', 'type': 'NIH'}, {'id': 'UG1HD027853', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD027853', 'type': 'NIH'}, {'id': 'UG1HD040689', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD040689', 'type': 'NIH'}, {'id': 'UG1HD040492', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD040492', 'type': 'NIH'}, {'id': 'UG1HD027851', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD027851', 'type': 'NIH'}, {'id': 'UG1HD087229', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD087229', 'type': 'NIH'}, {'id': 'UG1HD053109', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD053109', 'type': 'NIH'}, {'id': 'UG1HD068278', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD068278', 'type': 'NIH'}, {'id': 'UG1HD068244', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD068244', 'type': 'NIH'}, {'id': 'UG1HD068263', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD068263', 'type': 'NIH'}, {'id': 'UG1HD027880', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD027880', 'type': 'NIH'}, {'id': 'UG1HD053089', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD053089', 'type': 'NIH'}, {'id': 'UG1HD087226', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD087226', 'type': 'NIH'}, {'id': 'UG1HD112079', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD112079', 'type': 'NIH'}, {'id': 'UG1HD112097', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD112097', 'type': 'NIH'}, {'id': 'UG1HD112100', 'link': 'https://reporter.nih.gov/quickSearch/UG1HD112100', 'type': 'NIH'}, {'id': '3U24HD095254-07', 'link': 'https://reporter.nih.gov/quickSearch/3U24HD095254-07', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'budesonide with surfactant', 'description': 'Infants randomized to the intervention arm receive a dose of surfactant (poractant alfa; Curosurf) mixed with budesonide (Pulmicort nebulizing suspension) within 50 hours of birth and administered via endotracheal tube.', 'interventionNames': ['Drug: budesonide (Pulmicort nebulizing suspension).']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'surfactant alone', 'description': 'Infants randomized to the active control arm receive a dose of surfactant (poractant alfa; Curosurf).', 'interventionNames': ['Drug: surfactant (poractant alfa;Curosurf)']}], 'interventions': [{'name': 'budesonide (Pulmicort nebulizing suspension).', 'type': 'DRUG', 'otherNames': ['Pulmicort nebulizing suspension.'], 'description': 'The first dose of budesonide is 0.25 mg/kg in a volume of 1 ml/kg, for a total volume of 2.5 ml/kg of Curosurf + 1 ml/kg of budesonide. If the infant is to receive a second dose of study drug within 50 hours of birth, the dosage of Curosurf is 1.25 ml/kg for the second dose and 1 ml/kg of budesonide.', 'armGroupLabels': ['budesonide with surfactant']}, {'name': 'surfactant (poractant alfa;Curosurf)', 'type': 'DRUG', 'otherNames': ['poractant alfa;Curosurf'], 'description': 'The first dose of surfactant (poractant alfa; Curosurf) is 2.5 ml/kg. If the infant is to receive a second dose of study drug within 50 hours of birth, the dosage of Curosurf is 1.25 ml/kg for the second dose.', 'armGroupLabels': ['surfactant alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249-7335', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'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': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Northwestern Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': "University of Mississippi Medical Center - Children's of Mississippi", 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'RTI International', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Case Western Reserve University, Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Research Institute at Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University - Women and Infants Hospital of Rhode Island', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Namasivayam Ambalavanan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Neonatal Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}