Viewing Study NCT02074059

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Ignite Creation Date: 2025-12-24 @ 2:23 PM
Ignite Modification Date: 2026-02-04 @ 8:04 AM
Study NCT ID: NCT02074059
Status: COMPLETED
Last Update Posted: 2017-04-21
First Post: 2014-02-25
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502722', 'term': 'lucinactant'}, {'id': 'D001239', 'term': 'Inhalation'}, {'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'psimmons@windtreetx.com', 'phone': '215-488-9300', 'title': 'Executive Director, Biostatistics & Data Management', 'phoneExt': '9477', 'organization': 'Windtree Therapeutics, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to 36 weeks post-menstrual age (PMA). As infants are enrolled at a gestational age of 29 to 34 weeks PMA, this represents a period of 2 to 7 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Aerolized Lucinactant (25 mg/kg)', 'description': '25 mg TPL/kg of Lucinactant for inhalation with nCPAP', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Aerosolized Lucinactant (50 mg/kg)', 'description': '50 mg TPL/kg of Lucinactant for inhalation with nCPAP', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Aerosolized Lucinactant (75 mg/kg)', 'description': '75 mg TPL/kg of Lucinactant for inhalation with nCPAP', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Aerosolized Lucinactant (100 mg/kg)', 'description': '100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Aerosolized Lucinactant (150 mg/kg)', 'description': '150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'nCPAP Alone', 'description': 'nCPAP therapy alone', 'otherNumAtRisk': 40, 'otherNumAffected': 37, 'seriousNumAtRisk': 40, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Anaemia Neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Acrochordon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Alveolar Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Apnoea Neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood Thyroid Stimulating Hormone Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood Urea Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood Urea Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Bradypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Bronchopulmonary Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'C-reactive Protein Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Candida Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cardiac Murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Catheter Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cephalhaematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'CNS Ventriculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Congenital Choroid Plexus Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Congenital Naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.0', 'spread': '0', 'groupId': 'OG000'}, {'value': '92.7', 'spread': '4.68', 'groupId': 'OG001'}, {'value': '94.8', 'spread': '5.15', 'groupId': 'OG002'}, {'value': '94.8', 'spread': '3.62', 'groupId': 'OG003'}, {'value': '92.0', 'spread': '4.66', 'groupId': 'OG004'}, {'value': '93.3', 'spread': '3.39', 'groupId': 'OG005'}]}]}, {'title': '30 Minutes Post Randomization/Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '93.5', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '92.3', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '92.5', 'spread': '5.95', 'groupId': 'OG002'}, {'value': '93.3', 'spread': '4.83', 'groupId': 'OG003'}, {'value': '91.4', 'spread': '3.89', 'groupId': 'OG004'}, {'value': '93.6', 'spread': '3.33', 'groupId': 'OG005'}]}]}, {'title': '45 Minutes Post Randomization/Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '94.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '91.3', 'spread': '3.88', 'groupId': 'OG001'}, {'value': '94.0', 'spread': '4.72', 'groupId': 'OG002'}, {'value': '93.8', 'spread': '3.11', 'groupId': 'OG003'}, {'value': '93.0', 'spread': '2.27', 'groupId': 'OG004'}, {'value': '93.7', 'spread': '3.04', 'groupId': 'OG005'}]}]}, {'title': '60 Minutes Post 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'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '140', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '137', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '139', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '140', 'spread': '4.9', 'groupId': 'OG003'}, {'value': '137', 'spread': '4.3', 'groupId': 'OG004'}, {'value': '139', 'spread': '3.3', 'groupId': 'OG005'}]}]}, {'title': 'Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '108', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '107', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '107', 'spread': '6.6', 'groupId': 'OG002'}, {'value': '107', 'spread': '6.3', 'groupId': 'OG003'}, {'value': '105', 'spread': '4.5', 'groupId': 'OG004'}, {'value': '108', 'spread': '3.5', 'groupId': 'OG005'}]}]}, {'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.86', 'spread': '0.262', 'groupId': 'OG000'}, {'value': '4.66', 'spread': '1.235', 'groupId': 'OG001'}, {'value': '3.86', 'spread': '0.453', 'groupId': 'OG002'}, {'value': '4.46', 'spread': '1.029', 'groupId': 'OG003'}, {'value': '4.09', 'spread': '0.993', 'groupId': 'OG004'}, {'value': '4.47', 'spread': '1.082', 'groupId': 'OG005'}]}]}, {'title': 'Total Carbon Dioxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': 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'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': '12.73', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '8.37', 'groupId': 'OG001'}, {'value': '48.4', 'spread': '12.13', 'groupId': 'OG002'}, {'value': '44.7', 'spread': '9.62', 'groupId': 'OG003'}, {'value': '55.0', 'spread': '4.20', 'groupId': 'OG004'}, {'value': '48.1', 'spread': '9.84', 'groupId': 'OG005'}]}]}, {'title': '45 Minutes Post Randomization/Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '32.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '7.94', 'groupId': 'OG001'}, {'value': '46.2', 'spread': '9.41', 'groupId': 'OG002'}, {'value': '45.1', 'spread': '10.27', 'groupId': 'OG003'}, {'value': '52.6', 'spread': '6.68', 'groupId': 'OG004'}, {'value': '47.1', 'spread': '9.67', 'groupId': 'OG005'}]}]}, {'title': '60 Minutes Post Randomization/Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '49.7', 'spread': '9.62', 'groupId': 'OG001'}, {'value': '47.3', 'spread': '11.53', 'groupId': 'OG002'}, {'value': '46.2', 'spread': '10.02', 'groupId': 'OG003'}, {'value': '51.6', 'spread': '7.62', 'groupId': 'OG004'}, {'value': '47.8', 'spread': '7.85', 'groupId': 'OG005'}]}]}, {'title': '1.25 Hours Post Randomization/Treatment', 'denoms': [{'units': 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'spread': '2.10', 'groupId': 'BG003'}, {'value': '32.3', 'spread': '1.95', 'groupId': 'BG004'}, {'value': '31.5', 'spread': '1.56', 'groupId': 'BG005'}, {'value': '31.7', 'spread': '1.74', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized subjects'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential escalating dosing groups, each group contained an active and control arm of equal size.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2014-02-25', 'resultsFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2014-02-26', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-10', 'studyFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri-Dosing Events', 'timeFrame': 'Within 48 Hours after Initiation of Study Treatment', 'description': 'Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone'}, {'measure': 'All Cause Mortality', 'timeFrame': 'Within 36 Weeks PMA'}, {'measure': 'Oxygen Saturation Levels', 'timeFrame': 'Within 3 Hours of Randomization', 'description': 'Oxygen saturation as determined by pulse oximetry'}, {'measure': 'Serum Electrolytes', 'timeFrame': '24 Hours Post Randomization'}], 'secondaryOutcomes': [{'measure': 'PCO2', 'timeFrame': 'Within 3 Hours of Randomization', 'description': 'Arterial carbon dioxide'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '29 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent from a legally authorized representative\n* Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)\n* Successful implementation of controlled nCPAP within 90 minutes after birth\n* Spontaneous breathing\n* Chest radiograph consistent with RDS\n* Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth\n\nExclusion Criteria:\n\n* Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth\n* Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface\n* A 5 minute Apgar score \\< 5\n* Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth\n* Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)\n* Known or suspected chromosomal abnormality or syndrome\n* Prolong rupture of membranes (PROM) \\> 2 weeks\n* Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis\n* Need for endotracheal intubation and mechanical ventilation\n* Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth'}, 'identificationModule': {'nctId': 'NCT02074059', 'briefTitle': 'Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates', 'organization': {'class': 'INDUSTRY', 'fullName': 'Windtree Therapeutics'}, 'officialTitle': 'A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 29 to 34 Weeks PMA: Dose Escalation and Study Extension', 'orgStudyIdInfo': {'id': '03-CL-1201'}, 'secondaryIdInfos': [{'id': '4R44HL107000-02', 'link': 'https://reporter.nih.gov/quickSearch/4R44HL107000-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerosolized lucinactant (25 mg/kg)', 'description': '25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP', 'interventionNames': ['Drug: Lucinactant for Inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Aerosolized lucinactant (50 mg/kg)', 'description': '50 mg TPL/kg: Lucinactant for inhalation with nCPAP', 'interventionNames': ['Drug: Lucinactant for Inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Aerosolized lucinactant (75 mg/kg)', 'description': '75 mg TPL/kg: Lucinactant for inhalation with nCPAP', 'interventionNames': ['Drug: Lucinactant for Inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Aerosolized lucinactant (100 mg/kg)', 'description': '100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.', 'interventionNames': ['Drug: Lucinactant for Inhalation']}, {'type': 'EXPERIMENTAL', 'label': 'Aerosolized lucinactant (150 mg/kg)', 'description': '150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.', 'interventionNames': ['Drug: Lucinactant for Inhalation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nCPAP alone', 'description': 'nCPAP therapy alone', 'interventionNames': ['Device: nCPAP alone']}], 'interventions': [{'name': 'Lucinactant for Inhalation', 'type': 'DRUG', 'otherNames': ['Aerosurf'], 'description': 'Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)', 'armGroupLabels': ['Aerosolized lucinactant (100 mg/kg)', 'Aerosolized lucinactant (150 mg/kg)', 'Aerosolized lucinactant (25 mg/kg)', 'Aerosolized lucinactant (50 mg/kg)', 'Aerosolized lucinactant (75 mg/kg)']}, {'name': 'nCPAP alone', 'type': 'DEVICE', 'otherNames': ['nasal continuous positive airway pressure'], 'description': 'nCPAP therapy', 'armGroupLabels': ['nCPAP alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mary Birch Hospital for Women and Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children at IU Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Mid Atlantic Neonatology Associates', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Robert Segal, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Windtree Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Windtree Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}