Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-27 @ 12:52 AM
Study NCT ID:
NCT03969992
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C078272', 'term': 'SF-RI 1, bovine surfactant preparation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ddurand@aerogenpharma.com', 'phone': '510-928-2111', 'title': 'David Durand, MD', 'organization': 'Aerogen Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs and SAEs were collected from randomization through NICU discharge or 40 weeks post-menstrual age (PMA) in Part 1. Only fatal SAEs were collected for up to 12 months in Part 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 43, 'seriousNumAtRisk': 92, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 45, 'seriousNumAtRisk': 83, 'deathsNumAffected': 3, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 42, 'seriousNumAtRisk': 86, 'deathsNumAffected': 2, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Intraventricular hemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Retinopathy or prematurity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Infantile apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pulmonary hemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 4}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Necrotizing enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bradycardia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Patent ductus arteriosus repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Necrotizing enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Meconium ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pulmonary hemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardiac dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Intraventricular hemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intubation/Cannulation and Instilled Surfactant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone'}, {'id': 'OG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1'}, {'id': 'OG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1924', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'A closed test procedure is used to protect the type I error rate; the order of testing was: AeroFact high dose compared to control and if significant (p-value \\<0.05), the AeroFact low dose was compared to the control.', 'statisticalMethod': 'Generalized estimating equation method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First 7 days of life', 'description': 'Number of patients who require intubation/cannulation with bolus surfactant instillation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population'}, {'type': 'SECONDARY', 'title': 'Time to First Intubation/Cannulation and Bolus Surfactant Instillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone'}, {'id': 'OG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1'}, {'id': 'OG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '53.9'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '43.4'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '53.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First 7 days of life', 'description': 'Time from randomization to intubation/cannulation and bolus surfactant instillation in the first 7 days of life', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Proportion of Infants Who Received Multiple Doses of Bolus Surfactant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone'}, {'id': 'OG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1'}, {'id': 'OG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First 7 days of life', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Number of Days on Invasive Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone'}, {'id': 'OG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1'}, {'id': 'OG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '16.7', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '4.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed daily from birth to 40 weeks post-menstrual age or discharge', 'description': 'Total number of days each participant required support with invasive mechanical ventilation', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone'}, {'id': 'OG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1'}, {'id': 'OG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to 36 weeks post-menstrual age', 'description': 'Total number of patients per treatment group who were alive and did not experience BPD at 36 weeks PMA', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone'}, {'id': 'OG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1'}, {'id': 'OG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to 40 weeks post-menstrual age', 'description': 'Total number of patients per treatment group who were alive and did not experience BPD at 40 weeks PMA', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone'}, {'id': 'FG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact 108 mg/kg/dose'}, {'id': 'FG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact 216 mg/kg/dose'}], 'periods': [{'title': 'Part 1: Birth to Discharge/40 Weeks PMA', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Part 2: Discharge/40 Wks PMA to 12 Mos', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '261', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control: nCPAP Alone', 'description': 'nCPAP (nasal continuous positive airway pressure) alone'}, {'id': 'BG001', 'title': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1'}, {'id': 'BG002', 'title': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '29.1', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '29.2', 'spread': '1.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Gestational age in weeks', 'unitOfMeasure': 'weeks gestational age', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth weight', 'classes': [{'categories': [{'measurements': [{'value': '1195.1', 'spread': '297.9', 'groupId': 'BG000'}, {'value': '1245.1', 'spread': '301.5', 'groupId': 'BG001'}, {'value': '1248.7', 'spread': '303.9', 'groupId': 'BG002'}, {'value': '1228.7', 'spread': '300.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vaginal delivery', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Multiple gestation', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '9.1', 'spread': '6.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FiO2 at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.05', 'groupId': 'BG000'}, {'value': '0.27', 'spread': '0.04', 'groupId': 'BG001'}, {'value': '0.27', 'spread': '0.05', 'groupId': 'BG002'}, {'value': '0.27', 'spread': '0.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Fraction of inspired oxygen; Higher scores indicate more supplemental oxygen was needed', 'unitOfMeasure': 'Percentage of inspired oxygen', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Respiratory Severity Score at Randomization', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.3', 'groupId': 'BG002'}, {'value': '1.7', 'spread': '0.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'mean airway pressure \\[MAP\\] × FiO2; Higher scores suggest greater breathing difficulty', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized patients were included in the ITT and Safety analysis populations, regardless of whether or not they received study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-09', 'size': 1522773, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-24T11:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking within active arms'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Partially Blinded, Randomized, Parallel-Group Dose Ranging'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2019-04-05', 'resultsFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2019-05-30', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-04', 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation/Cannulation and Instilled Surfactant', 'timeFrame': 'First 7 days of life', 'description': 'Number of patients who require intubation/cannulation with bolus surfactant instillation'}], 'secondaryOutcomes': [{'measure': 'Time to First Intubation/Cannulation and Bolus Surfactant Instillation', 'timeFrame': 'First 7 days of life', 'description': 'Time from randomization to intubation/cannulation and bolus surfactant instillation in the first 7 days of life'}, {'measure': 'Proportion of Infants Who Received Multiple Doses of Bolus Surfactant', 'timeFrame': 'First 7 days of life'}, {'measure': 'Number of Days on Invasive Mechanical Ventilation', 'timeFrame': 'Assessed daily from birth to 40 weeks post-menstrual age or discharge', 'description': 'Total number of days each participant required support with invasive mechanical ventilation'}, {'measure': 'Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA)', 'timeFrame': 'Birth to 36 weeks post-menstrual age', 'description': 'Total number of patients per treatment group who were alive and did not experience BPD at 36 weeks PMA'}, {'measure': 'Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA)', 'timeFrame': 'Birth to 40 weeks post-menstrual age', 'description': 'Total number of patients per treatment group who were alive and did not experience BPD at 40 weeks PMA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Distress Syndrome', 'BPD', 'surfactant', 'Preterm Infant'], 'conditions': ['Respiratory Distress Syndrome in Premature Infant']}, 'descriptionModule': {'briefSummary': 'The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.', 'detailedDescription': 'Part I Primary Objective To determine an optimal dose of AeroFact administered by nasal continuous positive airway pressure (nCPAP) versus stand of care in reducing the rate of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth.\n\nPart II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '31 Weeks', 'minimumAge': '26 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)\n2. 26 0/7 to 30 6/7 weeks of gestational age\n3. Weight \\<2.0 Kg\n4. Respiratory Severity Score (RSS) 1.4-2.0\n\nExclusion Criteria:\n\n1. Apgar score less than or equal to 5 at five minutes after birth\n2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room\n3. Premature rupture of membranes (PROM) \\> 14 days\n4. Need for intubation and/or mechanical ventilation prior to enrollment\n5. Active pneumothorax requiring chest tube\n6. Significant congenital anomaly, chromosomal abnormality\n7. Concomitant treatments with inhaled nitric oxide'}, 'identificationModule': {'nctId': 'NCT03969992', 'briefTitle': 'A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aerogen Pharma Limited'}, 'officialTitle': 'A Partially Blinded, Randomized, Controlled, Parallel-Group, Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'APC-AF-CLN-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'nCPAP alone', 'description': 'Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary', 'interventionNames': ['Other: nCPAP']}, {'type': 'EXPERIMENTAL', 'label': 'Drug: Low Dose AeroFact', 'description': 'AeroFact-low dose SF-RI 1', 'interventionNames': ['Drug: AeroFact']}, {'type': 'EXPERIMENTAL', 'label': 'Drug: High Dose AeroFact', 'description': 'AeroFact-high dose SF-RI 1', 'interventionNames': ['Drug: AeroFact']}], 'interventions': [{'name': 'AeroFact', 'type': 'DRUG', 'otherNames': ['SF-RI 1'], 'description': 'Aerosolized SF-RI 1', 'armGroupLabels': ['Drug: High Dose AeroFact', 'Drug: Low Dose AeroFact']}, {'name': 'nCPAP', 'type': 'OTHER', 'description': 'nCPAP (nasal continuous positive airway pressure) alone', 'armGroupLabels': ['nCPAP alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital 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'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Hospital', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mt. 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