Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-04-22 @ 1:09 AM
Study NCT ID:
NCT02510560
Status:
TERMINATED
Last Update Posted:
2025-08-19
First Post:
2015-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}], 'ancestors': [{'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'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Miki@elganpharma.com', 'phone': '972-4-6098626', 'title': 'Miki Olshansky, Chief Executive Officer', 'organization': 'Elgan Pharma Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '18 months', 'eventGroups': [{'id': 'EG000', 'title': 'NTRA-2112 A', 'description': 'NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 91, 'seriousNumAtRisk': 108, 'deathsNumAffected': 5, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'NTRA-2112 B', 'description': 'NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 70, 'seriousNumAtRisk': 88, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nPlacebo', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 81, 'seriousNumAtRisk': 97, 'deathsNumAffected': 4, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Anaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'patent ductus arteriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 9}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrotising enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ophthalmia neonatorum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraventricular haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaundice neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infantile apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchopulmonary dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrotising enterocolitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrotising colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraventricular haemorrhage neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchopulmonary dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'patent ductus arteriosus repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iliac vein occulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numbers of Days to Achieve Complete Enteral Feeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NTRA-2112 A', 'description': 'NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112'}, {'id': 'OG001', 'title': 'NTRA-2112 B', 'description': 'NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '6.09', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '5.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.115', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Stratified Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.243', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Stratified Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '28 days or discharge from hospital', 'description': 'Numbers of days to achieve full enteral feeding (NFE) is defined as:\n\nNumber of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Days to Achieve Discharge From Hospital or Readiness to Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NTRA-2112 A', 'description': 'NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112'}, {'id': 'OG001', 'title': 'NTRA-2112 B', 'description': 'NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '16.26', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '14.36', 'groupId': 'OG001'}, {'value': '36', 'spread': '15.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.714', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Stratified Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.243', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Stratified Van Elteren Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '28 days or discharge from hospital', 'description': 'Readiness for discharge from hospital is defined as achieving all of the below:\n\n* Infant weight ≥ 1800g\n* Stable body temperature\n* Capable of oral feeding (reached full enteral feeding and not dependent on PN)', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NTRA-2112 A', 'description': 'NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112'}, {'id': 'FG001', 'title': 'NTRA-2112 B', 'description': 'NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 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'title': 'NTRA-2112 A', 'description': 'NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112'}, {'id': 'BG001', 'title': 'NTRA-2112 B', 'description': 'NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nNTRA-2112'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.\n\nPlacebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '26-28 weeks', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}]}, {'title': '29-32 weeks', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '169', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 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'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Due to early study termination by the Sponsor, only 300 of the 450 intended subjects were enrolled.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-10', 'size': 10883780, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-22T09:16', 'hasProtocol': True}, {'date': '2017-05-10', 'size': 995184, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-22T09:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2015-07-24', 'resultsFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2015-07-26', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-22', 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of Days to Achieve Complete Enteral Feeding', 'timeFrame': '28 days or discharge from hospital', 'description': 'Numbers of days to achieve full enteral feeding (NFE) is defined as:\n\nNumber of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.'}], 'secondaryOutcomes': [{'measure': 'Number of Days to Achieve Discharge From Hospital or Readiness to Discharge', 'timeFrame': '28 days or discharge from hospital', 'description': 'Readiness for discharge from hospital is defined as achieving all of the below:\n\n* Infant weight ≥ 1800g\n* Stable body temperature\n* Capable of oral feeding (reached full enteral feeding and not dependent on PN)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Premature Birth of Newborn', 'Intestinal Malabsorption']}, 'referencesModule': {'references': [{'pmid': '35226099', 'type': 'DERIVED', 'citation': 'Mank E, Saenz de Pipaon M, Lapillonne A, Carnielli VP, Senterre T, Shamir R, van Toledo L, van Goudoever JB; FIT-04 Study Group. Efficacy and Safety of Enteral Recombinant Human Insulin in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2022 May 1;176(5):452-460. doi: 10.1001/jamapediatrics.2022.0020.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.', 'detailedDescription': 'The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound\n2. Birth weight ≥ 500g\n3. Singleton or twin birth\n\nExclusion Criteria\n\n1\\. Complete enteral feeding'}, 'identificationModule': {'nctId': 'NCT02510560', 'briefTitle': 'Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elgan Pharma Ltd.'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants', 'orgStudyIdInfo': {'id': 'FIT-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NTRA-2112 A', 'description': 'NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.', 'interventionNames': ['Drug: NTRA-2112']}, {'type': 'EXPERIMENTAL', 'label': 'NTRA-2112 B', 'description': 'NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.', 'interventionNames': ['Drug: NTRA-2112']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NTRA-2112', 'type': 'DRUG', 'armGroupLabels': ['NTRA-2112 A', 'NTRA-2112 B']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Vidant Medical Center', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Rocourt', 'country': 'Belgium', 'facility': 'CHC Cliniques Saint-Vincent', 'geoPoint': {'lat': 50.67579, 'lon': 5.54621}}, {'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'GZA Sint-Augustinus', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'city': 'Nancy', 'country': 'France', 'facility': 'CHRU Nancy, Maternité Régionale', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Paris', 'country': 'France', 'facility': 'CHU Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU - 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