Viewing Study NCT00931632

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Ignite Creation Date: 2025-12-24 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
Study NCT ID: NCT00931632
Status: COMPLETED
Last Update Posted: 2017-12-04
First Post: 2009-07-01
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
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': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045462', 'term': 'Endothelium-Dependent Relaxing Factors'}, {'id': 'D009584', 'term': 'Nitrogen'}], 'ancestors': [{'id': 'D014665', 'term': 'Vasodilator Agents'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lawrence.hill@mallinckrodt.com', 'phone': '908-238-6370', 'title': 'Lawrence Hill', 'organization': 'Mallinckrodt'}, 'certainAgreement': {'otherDetails': "Site shall use Confidential Information solely for the purposes of preforming its obligations under the Clinical Study Agreement and shall not, without Sponsor's prior written consent, publish, disseminate or otherwise disclose to any third party (including any of its affiliates) any Confidential Information. These obligations shall survive and continue for ten years after the termination or expiration of the Agreement or such longer period as required by Applicable Law.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through treatment completion, up to 24 days', 'description': 'During treatment of 24 day course', 'eventGroups': [{'id': 'EG000', 'title': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide\n\nInhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.', 'otherNumAtRisk': 229, 'deathsNumAtRisk': 229, 'otherNumAffected': 169, 'seriousNumAtRisk': 229, 'deathsNumAffected': 12, 'seriousNumAffected': 105}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Nitrogen Placebo\n\nPlacebo: Nitrogen gas will be administered in the same manner as the experimental drug.', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 143, 'seriousNumAtRisk': 220, 'deathsNumAffected': 8, 'seriousNumAffected': 100}], 'otherEvents': [{'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 50}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Feeding disorder neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchopulmonary dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 34}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Necrotising enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Anemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hemolytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumopericardium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Persistent fetal circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Adrenogenital syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hereditary spherocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ileal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Esophageal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Group B streptococcus neonatal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Fungal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Beta hemolytic streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Enterococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung infection pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Staphylococcal bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Enterobacter sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Meningitis candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'CST culture positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Candida test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Intraventricular hemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cerebral ventricle dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Encephalomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Periventricular leukomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG001', 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discharge, an average of 105 days for placebo and 108 days for INO'}, {'measure': 'Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason', 'timeFrame': 'Through hospital discharge, an average of 105 days for placebo and 108 days for INO'}, {'measure': 'Systemic Use of Postnatal Corticosteroids for Any Medical Reason', 'timeFrame': 'Through hospital discharge, an average of 105 days for placebo and 108 days for INO'}, {'measure': 'Number of Days of Oxygen Use', 'timeFrame': 'Through hospital discharge, an average of 105 days for placebo and 108 days for INO'}, {'measure': 'Severity of Bronchopulmonary Dysplasia', 'timeFrame': '36 weeks', 'description': 'Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bronchopulmonary Dysplasia, BPD'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '28973344', 'type': 'RESULT', 'citation': 'Hasan SU, Potenziano J, Konduri GG, Perez JA, Van Meurs KP, Walker MW, Yoder BA; Newborns Treated With Nitric Oxide (NEWNO) Trial Group. Effect of Inhaled Nitric Oxide on Survival Without Bronchopulmonary Dysplasia in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Nov 1;171(11):1081-1089. doi: 10.1001/jamapediatrics.2017.2618.'}], 'seeAlsoLinks': [{'url': 'http://jamanetwork.com/journals/jamapediatrics/article-abstract/2654598', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.', 'detailedDescription': "Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '5 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants who are:\n\n 1. 500 to 1250 grams at birth\n 2. \\< 30 weeks gestational age\n 3. 5 to 14 days of age (inclusive) at the time of entry\n 4. Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)\n\nExclusion Criteria:\n\n1. Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care\n2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)\n3. Subjects who are dependent on right to left shunting to maintain the systemic circulation\n4. Preterm infants who received prior iNO therapy\n5. Use of another investigational agent'}, 'identificationModule': {'nctId': 'NCT00931632', 'briefTitle': 'Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth', 'orgStudyIdInfo': {'id': 'IK-3001-BPD-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled Nitric Oxide', 'description': 'Inhaled Nitric Oxide', 'interventionNames': ['Drug: Inhaled Nitric Oxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Nitrogen Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Inhaled Nitric Oxide', 'type': 'DRUG', 'otherNames': ['INOmax'], 'description': 'Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.', 'armGroupLabels': ['Inhaled Nitric Oxide']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Nitrogen gas'], 'description': 'Nitrogen gas will be administered in the same manner as the experimental drug.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University School of 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