Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-03 @ 12:38 AM
Study NCT ID:
NCT00578734
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502722', 'term': 'lucinactant'}, {'id': 'D013501', 'term': 'Surface-Active Agents'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nthomas@hmc.psu.edu', 'phone': '717-531-5337', 'title': 'Dr. Neal J. Thomas', 'organization': "Penn State Children's Hospital"}, 'certainAgreement': {'otherDetails': "First publication must be joint, multicenter publication in conjunction with a presentation. Following multicenter publication, proposed publications or presentations must be submitted to sponsor 30 days in advance. In the event of an objection by sponsor, PI agrees to delay the publication or presentation until modifications or revisions have been made to protect Sponsor's patent rights, copyrights, or proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 days from randomization or until resolution of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Lucinactant', 'description': 'KL₄Surfactant (lucinactant) endotracheal instillation', 'otherNumAtRisk': 84, 'otherNumAffected': 65, 'seriousNumAtRisk': 84, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Sham Air', 'description': 'Sham air (placebo) instillation', 'otherNumAtRisk': 81, 'otherNumAffected': 62, 'seriousNumAtRisk': 81, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Metabolic alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Coarctation of the aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hepatitis cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Neurological symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '4.6'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 14 Days', 'description': 'Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lucinactant', 'description': 'KL₄Surfactant (lucinactant) endotracheal instillation'}, {'id': 'OG001', 'title': 'Sham Air', 'description': 'Sham air (placebo) instillation'}], 'classes': [{'title': 'Ventilator-free days', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '5.9'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '5.3'}]}]}, {'title': 'Duration in Pediatric Intensive Care Unit (PICU)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '7.0'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '7.6'}]}]}, {'title': 'Duration of Supplemental Oxygen', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '8.7'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '9.0'}]}]}, {'title': 'Duration of Hospitalization', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '11.1'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '10.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 14 days', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lucinactant', 'description': 'KL₄Surfactant (lucinactant) endotracheal instillation'}, {'id': 'FG001', 'title': 'Sham Air', 'description': 'Sham air (placebo) instillation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Subjects were enrolled at 24 hospitals in the United States and Chile from 04 June, 2007 to 23 March, 2010. Last subject's last visit occurred on 05 April, 2010."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lucinactant', 'description': 'KL₄Surfactant (lucinactant) endotracheal instillation'}, {'id': 'BG001', 'title': 'Sham Air', 'description': 'Sham air (placebo) instillation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '165', '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': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '0.43', 'groupId': 'BG000'}, {'value': '0.45', 'spread': '0.43', 'groupId': 'BG001'}, {'value': '0.45', 'spread': '0.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-01', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2012-04-02', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-02', 'studyFirstPostDateStruct': {'date': '2007-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Mechanical Ventilation Through 14 Days', 'timeFrame': 'Up to 14 Days', 'description': 'Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.'}], 'secondaryOutcomes': [{'measure': 'Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days', 'timeFrame': 'Up to 14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Hypoxemic Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '22791092', 'type': 'DERIVED', 'citation': 'Thomas NJ, Guardia CG, Moya FR, Cheifetz IM, Markovitz B, Cruces P, Barton P, Segal R, Simmons P, Randolph AG; PALISI Network. A pilot, randomized, controlled clinical trial of lucinactant, a peptide-containing synthetic surfactant, in infants with acute hypoxemic respiratory failure. Pediatr Crit Care Med. 2012 Nov;13(6):646-53. doi: 10.1097/PCC.0b013e3182517bec.'}]}, 'descriptionModule': {'briefSummary': 'Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).', 'detailedDescription': 'Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 38 weeks (corrected age) to 2 years (24 months)\n* Intubated and mechanically ventilated (MV) for ≥ 6 hours and anticipated need for MV for ≥ 24 hours\n* Persistent hypoxia\n* Written informed consent\n\nExclusion Criteria:\n\n* Mechanical Ventilation for \\> 48 hours\n* Oxygenation index ≥ 25, if arterial line was avialable\n* Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange\n* Neuromuscular disease or hypotonia\n* Upper airway disease\n* Baseline requirment for supplemental oxygen\n* Untreated pneumothorax\n* Off-label use of commercially available surfactant outside neonatal period\n* History of prematurity and passive immunoprophylaxis with humanized monoclonal antibody\n* Head injury with Glasgow Coma Scale \\< 8\n* Brain death or impending brain death\n* Do not resuscitate orders\n* Cardiopulmonary resuscitation within 6 hours of meeting entry criteria\n* Experimental therapy in which the intervention potentially affects respiratory outcomes\n* Any transplant recipient\n* Meconium aspiration syndrome\n* Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection'}, 'identificationModule': {'nctId': 'NCT00578734', 'acronym': 'KL4-AHRF-01', 'briefTitle': 'Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'Windtree Therapeutics'}, 'officialTitle': 'A Multicenter, Randomized, Masked, Placebo-Controlled Trial to Assess the Safety and Efficacy of Lucinactant in Acute Hypoxemic Respiratory Failure in Children Up to Two Years of Age', 'orgStudyIdInfo': {'id': 'KL4-AHRF-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lucinactant', 'description': 'SURFAXIN® (lucinactant) for intratracheal instillation', 'interventionNames': ['Drug: Lucinactant']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Air', 'description': 'Sham air (placebo) instillation', 'interventionNames': ['Other: Sham Comparator']}], 'interventions': [{'name': 'Lucinactant', 'type': 'DRUG', 'otherNames': ['SURFAXIN®', 'Surfactant'], 'description': 'Slow intra-tracheal instillation', 'armGroupLabels': ['Lucinactant']}, {'name': 'Sham Comparator', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'Slow intra-tracheal instillation', 'armGroupLabels': ['Sham Air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18976', 'city': 'Warrington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Call for information', 'geoPoint': {'lat': 40.24927, 'lon': -75.13406}}, {'city': 'Concepción', 'country': 'Chile', 'facility': 'Call for Information', 'geoPoint': {'lat': -36.82699, 'lon': -73.04977}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Call For Information', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Neal Thomas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}, {'name': 'Adrienne Randolph, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Windtree Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}