Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00807235
Status:
TERMINATED
Last Update Posted:
2012-06-13
First Post:
2008-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rsegal@discoverylabs.com', 'phone': '215-488-9300', 'title': 'Robert Segal, MD', 'organization': 'Discovery Laboratories, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bradycardia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastro-oesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Jaundice neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acidosis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypermagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolic acidosis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Feeding problem in newborn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Agitation neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchopulmonary dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal passage irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neonatal apnoeic attach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intraventricular haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neonatal hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary hypertension NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neonatal apnoeic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary hypertension NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Respiratory Distress Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 hours', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours', 'description': 'AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward', 'unitOfMeasure': 'percent O₂*hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Arterial Alveolar (a/A) O₂Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.', 'unitOfMeasure': 'mm Hg over mm Hg (ratio of pressures)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Time to Meet Failure Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 28 days', 'description': 'Failure criteria defined as rescue with bolus surfactant and mechanical ventilation', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat). Time in days calculated for neonates who met failure criteria (3 for Regimen 1, 2 for Regimen 2)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bronchopulmonary Dysplasia (BPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Alive and Without BPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Patent Ductus Arteriosus (PDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Necrotizing Enterocolitis (NEC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pulmonary Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acquired Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Incidence of Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Air Leak', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'OG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.\n\nAll enrolled infants analyzed (intent-to-treat).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'FG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Neonates were enrolled between January and August, 2005. This was an open-label study with 2 treatment groups (Regimen 1 and Regimen 2). Eligible neonates were sequentially enrolled and stratified by GA into 2 strata for each regimen. For each regimen, enrollment in Stratum 1 (30 to 32 GA) was completed before enrollment in Stratum 2 (28 to 29 GA).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lucinactant - 3 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours'}, {'id': 'BG001', 'title': 'Lucinactant - 1 Hour Interval', 'description': 'Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational Age', 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '1.40', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '0.99', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '1.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-11', 'studyFirstSubmitDate': '2008-12-10', 'resultsFirstSubmitDate': '2012-04-02', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-11', 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Respiratory Distress Syndrome', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)', 'timeFrame': '0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours', 'description': 'AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward'}, {'measure': 'Arterial Alveolar (a/A) O₂Ratio', 'timeFrame': '72 hours', 'description': 'a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.'}, {'measure': 'Time to Meet Failure Criteria', 'timeFrame': 'Through 28 days', 'description': 'Failure criteria defined as rescue with bolus surfactant and mechanical ventilation'}, {'measure': 'Number of Participants With Bronchopulmonary Dysplasia (BPD)', 'timeFrame': '28 days'}, {'measure': 'Number of Participants Alive and Without BPD', 'timeFrame': '28 days'}, {'measure': 'Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)', 'timeFrame': '28 days'}, {'measure': 'Number of Participants With Patent Ductus Arteriosus (PDA)', 'timeFrame': '28 days'}, {'measure': 'Number of Participants With Necrotizing Enterocolitis (NEC)', 'timeFrame': '28 days'}, {'measure': 'Number of Participants With Pulmonary Hemorrhage', 'timeFrame': '28 days'}, {'measure': 'Number of Participants With Acquired Sepsis', 'timeFrame': '28 days'}, {'measure': 'Incidence of Mortality', 'timeFrame': '28 days'}, {'measure': 'Number of Participants With Air Leak', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lucinactant', 'Nasal continuous positive airway pressure (nCPAP)', 'Respiratory distress syndrome (RDS)', 'Pediatric', 'Premature'], 'conditions': ['Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '20455772', 'type': 'RESULT', 'citation': 'Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf(R) combined with nCPAP to prevent RDS in preterm neonates. J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.', 'detailedDescription': 'Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Minutes', 'minimumAge': '15 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 28-32 completed weeks, inclusive\n* Placement of arterial line\n* Successful initiation of nCPAP\n* Informed Consent\n\nExclusion Criteria:\n\n* Heart rate that cannot be stabilized \\>100 bpm within 5 minutes of birth\n* Five (5) minute Apgar score ≤ 3\n* Major congenital malformation(s) diagnosed antenatally or noted immediately after birth\n* Other disease(s) or conditions potentially interfering with cardiopulmonary function\n* Mother with prolonged rupture of membranes \\> 2 weeks\n* Known or suspected chromosomal abnormality\n* Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room\n* Need for mechanical ventilation within 30 minutes of birth'}, 'identificationModule': {'nctId': 'NCT00807235', 'briefTitle': 'Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Windtree Therapeutics'}, 'officialTitle': 'An Open Label, Multicenter, Phase 2, Pilot Evaluation of SURFAXIN®(Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants', 'orgStudyIdInfo': {'id': 'KL4-CPAP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen 1', 'interventionNames': ['Drug: Aerosolized lucinactant']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen 2', 'interventionNames': ['Drug: Aerosolized lucinactant']}], 'interventions': [{'name': 'Aerosolized lucinactant', 'type': 'DRUG', 'otherNames': ['KL₄Surfactant'], 'description': 'Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.', 'armGroupLabels': ['Regimen 1']}, {'name': 'Aerosolized lucinactant', 'type': 'DRUG', 'otherNames': ['KL₄Surfactant'], 'description': 'Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.', 'armGroupLabels': ['Regimen 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Medical Center - Hillcrest', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Neil Finer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Windtree Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}