Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01702805
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2012-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Transfusion of Prematures Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kirpalan@mcmaster.ca', 'phone': '267-844-3233', 'title': 'Haresh Kirpalani', 'organization': 'Emeritus Professor U Pennsylvania at CHOP and Emeritus Professor McMaster University, Dept Pediatrics'}, 'certainAgreement': {'otherDetails': 'Investigators must adhere to the Neonatal Research Network Publication Policies', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Birth to 37 weeks PMA', 'eventGroups': [{'id': 'EG000', 'title': 'High Tranfusion Threshold', 'description': 'Transfusions were administered using a higher threshold hemoglobin value. AKA "Liberal Cell Transfusion" group.', 'otherNumAtRisk': 908, 'deathsNumAtRisk': 903, 'otherNumAffected': 184, 'seriousNumAtRisk': 908, 'deathsNumAffected': 146, 'seriousNumAffected': 206}, {'id': 'EG001', 'title': 'Low Transfusion Threshold', 'description': 'Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the \'usual treatment\' group. AKA "Restricted Red Cell Transfusion" group.', 'otherNumAtRisk': 906, 'deathsNumAtRisk': 901, 'otherNumAffected': 164, 'seriousNumAtRisk': 906, 'deathsNumAffected': 135, 'seriousNumAffected': 197}], 'otherEvents': [{'term': 'Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory Deterioration up to 24 hours post-transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 146}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adrenal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': "Bell's stage > 2 Necrotizing Enterocolitis (NEC)", 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Esophageal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ischemic Bowel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Spontaneous Intestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Severe Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nosocomial Sepsis up to 24 hours post-transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sepsis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sepsis Fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sepsis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Severe Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Persistent Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary Air Leaks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory Deterioration up to 24 hours post-transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 85}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Severe Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 908, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '0.05'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Death or Neurodevelopmental Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '845', 'groupId': 'OG000'}, {'value': '847', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Death or Neurodevelopmental Impairment', 'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}, {'title': 'No Death nor Neurodevelopmental Impairment', 'measurements': [{'value': '422', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.10', 'groupDescription': 'Null hypothesis: A higher hemoglobin threshold for red-cell transfusions, as compared with a lower threshold, will not reduce nor increase the incidence of death or neurodevelopmental impairment in infants at 22 to 26 months of age corrected for prematurity.', 'statisticalMethod': 'Robust Poisson Regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The relative risk was adjusted for birth-weight and center stratum.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to 22-26 months corrected age', 'description': 'A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data for death and/or neurodevelopmental impairment.'}, {'type': 'PRIMARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}, {'value': '901', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Death', 'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}, {'title': 'No Death', 'measurements': [{'value': '757', 'groupId': 'OG000'}, {'value': '766', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to 22-26 months corrected age', 'description': 'This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available vital status.'}, {'type': 'PRIMARY', 'title': 'Neurodevelopmental Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Neurodevelopmental Impairment', 'measurements': [{'value': '277', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}, {'title': 'No Neurodevelopmental Impairment', 'measurements': [{'value': '422', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if any hearing impairment or visual impairment is noted, if severe or moderate cerebral palsy is noted, or if the cognitive score of the Bayley III score is more than 1 standard deviation below the average; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data for neurodevelopmental impairment.'}, {'type': 'PRIMARY', 'title': 'Cognitive Delay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Cognitive Delay', 'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}, {'title': 'No Cognitive Delay', 'measurements': [{'value': '426', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if the Bayley Scale of Infant and Toddler Development (BSID)-III cognitive score is more than 1 standard deviation below the average; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'PRIMARY', 'title': 'Moderate or Severe Cerebral Palsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '711', 'groupId': 'OG000'}, {'value': '720', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Moderate or Severe Cerebral Palsy', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Mild or No Cerebral Palsy', 'measurements': [{'value': '663', 'groupId': 'OG000'}, {'value': '665', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if the Gross Motor Function Classification System (GMFCS) score is level II or higher; Otherwise, No. Higher values of the GMFCS are worse than lower values; a level of "I" denotes mild cerebral palsy (CP); level "II" or "III" moderate CP; level "IV" or "V" severe CP.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'PRIMARY', 'title': 'Severe Vision Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '713', 'groupId': 'OG000'}, {'value': '720', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'No Severe Vision Impairment', 'measurements': [{'value': '708', 'groupId': 'OG000'}, {'value': '714', 'groupId': 'OG001'}]}, {'title': 'Severe Vision Impairment', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if the corrected visual acuity in the better eye of less than 20/200; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'PRIMARY', 'title': 'Severe Hearing Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '710', 'groupId': 'OG000'}, {'value': '715', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'No Severe Hearing Impairment', 'measurements': [{'value': '696', 'groupId': 'OG000'}, {'value': '690', 'groupId': 'OG001'}]}, {'title': 'Severe Hearing Impairment', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if bilateral hearing loss occurred for which hearing aids or cochlear implants were warranted; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Survival to Discharge Without Severe Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '901', 'groupId': 'OG000'}, {'value': '888', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'No Survival to Discharge Without Severe Complications', 'measurements': [{'value': '644', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}, {'title': 'Survival to Discharge Without Severe Complications', 'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as Yes if survived to discharge without severe morbidity, defined as bronchopulmonary dysplasia, retinopathy of prematurity (stage 3 or higher or requiring treatment), or serious brain abnormality; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data up to hospital discharge or death.'}, {'type': 'SECONDARY', 'title': 'Bronchopulmonary Dysplasia, Diagnosed on the Basis of the Need for Supplemental Oxygen After a Standardized Oxygen Reduction Test at 36 Weeks of Postmenstrual Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '795', 'groupId': 'OG000'}, {'value': '805', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Bronchopulmonary Dysplasia at 36 Weeks Postmenstrual Age', 'measurements': [{'value': '469', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}, {'title': 'No Bronchopulmonary Dysplasia at 36 Weeks Postmenstrual Age', 'measurements': [{'value': '326', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 36 weeks postmenstrual age', 'description': 'This is measured as Yes if experienced bronchopulmonary dysplasia, diagnosed on the basis of the need for supplemental oxygen after a standardized oxygen reduction test at 36 weeks of postmenstrual age; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at 36 weeks postmenstrual age.'}, {'type': 'SECONDARY', 'title': 'Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'OG000'}, {'value': '797', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'No Retinopathy of Prematurity at least Stage 3 and did not Receive Treatment for Such Condition', 'measurements': [{'value': '640', 'groupId': 'OG000'}, {'value': '660', 'groupId': 'OG001'}]}, {'title': 'Retinopathy of Prematurity at least Stage 3 or Received Treatment for Such Condition', 'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as Yes if experienced Retinopathy of Prematurity (ROP) Stage \\>=3 or received treatment for that condition; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data up to hospital discharge or death.'}, {'type': 'SECONDARY', 'title': 'Grade 3 or 4 Intraventricular Hemorrhage, Cystic Periventricular Leukomalacia, or Ventriculomegaly Diagnosed on Ultrasonographic Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '855', 'groupId': 'OG000'}, {'value': '859', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Grade 3 or 4 intraventricular hemorrhage, cystic periventricular leukomalacia, or ventriculomegaly', 'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}, {'title': 'None of the stated head ultrasound diagnoses', 'measurements': [{'value': '709', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as Yes if experienced Grade 3 or 4 intraventricularhemorrhage, cystic periventricular leukomalacia, or ventriculomegaly diagnosed on ultrasonographic examination; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data up to hospital discharge or death.'}, {'type': 'SECONDARY', 'title': "Necrotizing Enterocolitis, Bell's Stage >=2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}, {'value': '906', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': "NEC, Bell's Stage >= 2", 'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}, {'title': "NEC, Bell's Stage = 1 or no NEC", 'measurements': [{'value': '816', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as Yes if experienced necrotizing enterocolitis (NEC), Bell\'s stage \\>=2; Otherwise, No. Higher scores of Bell\'s staging criteria denote a worse outcome, where "1" denotes suspect, "2" definite and "3" advanced NEC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data up to hospital discharge or death.'}, {'type': 'SECONDARY', 'title': 'Number of Transfusions Per Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'OG000'}, {'value': '913', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth, up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age (PMA)', 'description': 'This is measured as the number of protocol compliant transfusions, clinically justified non-protocol transfusions and unjustified non-protocol transfusions (violations)', 'unitOfMeasure': 'Transfusions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data up to death, hospital discharge, or 36 weeks PMA, whichever occurs first'}, {'type': 'SECONDARY', 'title': 'Weight-for-age: Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '769', 'groupId': 'OG000'}, {'value': '774', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first', 'description': 'This is measured as the weight-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average weight-for-age, and negative scores denote less than average weight-for-age.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first.'}, {'type': 'SECONDARY', 'title': 'Length-for-age: Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '715', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first', 'description': 'This is measured as the length-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average length-for-age, and negative scores denote less than average length-for-age.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first.'}, {'type': 'SECONDARY', 'title': 'Head Circumference-for-age: Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '754', 'groupId': 'OG000'}, {'value': '766', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first', 'description': 'This is measured as the head circumference-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first.'}, {'type': 'SECONDARY', 'title': 'Postmenstrual Age at Final Trachael Extubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '796', 'groupId': 'OG000'}, {'value': '804', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '30.2', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at final trachael extubation, assessed from birth up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age', 'description': 'This is measured as the average postmenstrual age (in weeks) at final tracheal extubation in infants who were intubated.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data on trachael extubation.'}, {'type': 'SECONDARY', 'title': 'Postmenstrual Age at Final Caffeine Dose in Infants Who Received Caffeine Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '882', 'groupId': 'OG000'}, {'value': '887', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at final caffeine dose, assessed from birth up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age', 'description': 'This is measured as the average postmenstrual age (in weeks) at final caffeine dose in infants who received caffeine treatment.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data on caffeine treatment.'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}, {'value': '906', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '129'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '127'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at initial hospital discharge or at death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as the length of stay (in days) up to initial hospital discharge or death, whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data up to the initial hospital discharge or death, whichever occurs first.'}, {'type': 'SECONDARY', 'title': 'Time to Full Enteral Feeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '808', 'groupId': 'OG000'}, {'value': '824', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '29'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at first full enteral feeding, assessed from birth up to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as the amount of days it took for full enteral feeding to occur.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data on enteral feeding.'}, {'type': 'SECONDARY', 'title': 'Severe Cerebral Palsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '710', 'groupId': 'OG000'}, {'value': '720', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'No Severe Cerebral Palsy', 'measurements': [{'value': '690', 'groupId': 'OG000'}, {'value': '709', 'groupId': 'OG001'}]}, {'title': 'Severe Cerebral Palsy', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if Gross Motor Function Classification System (GMFCS) is levels IV or V; Otherwise, No. Higher values of the GMFCS are worse than lower values; a level of "I" denotes mild cerebral palsy (CP); level "II" or "III" moderate CP; level "IV" or "V" severe CP.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Hydrocephalus Shunt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}, {'value': '728', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Hydrocephalus Shunt', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'No Hydrocephalus Shunt', 'measurements': [{'value': '697', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial hospital discharge to 22-26 months corrected age', 'description': 'This is measured as Yes if experienced Hydrocephalus shunt by follow-up; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Microcephaly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Microcephaly', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'No Microcephaly', 'measurements': [{'value': '639', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as a head circumference-for-age Z-score of less than -2; Otherwise, No. The Z-score is determined using WHO percentile curves, and is derived from a normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Seizure Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'No Seizure disorder', 'measurements': [{'value': '672', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}]}, {'title': 'Seizure disorder', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial hospital discharge to 22-26 months corrected age', 'description': 'This is measured as Yes if experienced one or more seizures since discharge or of regular use of anticonvulsants or seizure medications; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Respiratory Disease Necessitating Readmission Before Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'No Respiratory disease necessitating readmission before follow-up', 'measurements': [{'value': '467', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}, {'title': 'Respiratory disease necessitating readmission before follow-up', 'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial hospital discharge to 22-26 months corrected age', 'description': 'This is measured as Yes if obtained Respiratory disease necessitating readmission before follow-up; Otherwise, No.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Composite Language Score Less Than 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '691', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Composite language score greater or equal to 85', 'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}, {'title': 'Composite language score less than 85', 'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite language score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Composite Motor Score Less Than 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Composite motor score greater or equal to 85', 'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}, {'title': 'Composite motor score less than 85', 'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite motor score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Composite Cognitive Score Less Than 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Composite cognitive score greater or equal to 70', 'measurements': [{'value': '607', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}]}, {'title': 'Composite cognitive score less than 70', 'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Composite Language Score Less Than 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '691', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Composite language score greater or equal to 70', 'measurements': [{'value': '507', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}, {'title': 'Composite language score less than 70', 'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite language score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}, {'type': 'SECONDARY', 'title': 'Composite Motor Score Less Than 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'OG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}], 'classes': [{'categories': [{'title': 'Composite motor score greater or equal to 70', 'measurements': [{'value': '591', 'groupId': 'OG000'}, {'value': '596', 'groupId': 'OG001'}]}, {'title': 'Composite motor score less than 70', 'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite motor score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all randomized infants with available data at the two-year followup.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Tranfusion Threshold', 'description': 'Transfusions were administered using a higher threshold hemoglobin value. AKA "Liberal Cell Transfusion" group.'}, {'id': 'FG001', 'title': 'Low Transfusion Threshold', 'description': 'Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the \'usual treatment\' group. AKA "Restricted Red Cell Transfusion" group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '911'}, {'groupId': 'FG001', 'numSubjects': '913'}]}, {'type': 'Completed Assessment for Neurodevelopmental Impairment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '699'}, {'groupId': 'FG001', 'numSubjects': '712'}]}, {'type': 'Died After Discharge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Died Before Discharge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'Survived to Discharge', 'achievements': [{'groupId': 'FG000', 'numSubjects': '781'}, {'groupId': 'FG001', 'numSubjects': '781'}]}, {'type': 'COMPLETED', 'comment': 'Complete data for Primary Outcome, Death or Neurodevelopmental Impairment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '845'}, {'groupId': 'FG001', 'numSubjects': '847'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Data withdrawn prior to hospital discharge', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Incomplete Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Vital Status Assessment Only', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '911', 'groupId': 'BG000'}, {'value': '913', 'groupId': 'BG001'}, {'value': '1824', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Transfusion Threshold', 'description': "Transfusions were administered using a higher threshold hemoglobin value. AKA 'Liberal Cell Transfusion' group."}, {'id': 'BG001', 'title': 'Low Transfusion Threshold', 'description': "Transfusions were administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group. AKA 'Restricted Red C"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age refers to the infant and is measured as gestational age in weeks', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '488', 'groupId': 'BG000'}, {'value': '462', 'groupId': 'BG001'}, {'value': '950', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '423', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '874', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '754', 'groupId': 'BG000'}, {'value': '753', 'groupId': 'BG001'}, {'value': '1507', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Race, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Asian, Native Hawaiian, or Other Pacific Islander', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '423', 'groupId': 'BG000'}, {'value': '395', 'groupId': 'BG001'}, {'value': '818', 'groupId': 'BG002'}]}, {'title': 'More Than One Race', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '419', 'groupId': 'BG000'}, {'value': '437', 'groupId': 'BG001'}, {'value': '856', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-07', 'size': 612988, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-02T15:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1824}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2012-08-30', 'resultsFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2012-10-05', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-01-18', 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death or Neurodevelopmental Impairment', 'timeFrame': 'Birth to 22-26 months corrected age', 'description': 'A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected age.'}, {'measure': 'Death', 'timeFrame': 'Birth to 22-26 months corrected age', 'description': 'This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No.'}, {'measure': 'Neurodevelopmental Impairment', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if any hearing impairment or visual impairment is noted, if severe or moderate cerebral palsy is noted, or if the cognitive score of the Bayley III score is more than 1 standard deviation below the average; Otherwise, No.'}, {'measure': 'Cognitive Delay', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if the Bayley Scale of Infant and Toddler Development (BSID)-III cognitive score is more than 1 standard deviation below the average; Otherwise, No.'}, {'measure': 'Moderate or Severe Cerebral Palsy', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if the Gross Motor Function Classification System (GMFCS) score is level II or higher; Otherwise, No. Higher values of the GMFCS are worse than lower values; a level of "I" denotes mild cerebral palsy (CP); level "II" or "III" moderate CP; level "IV" or "V" severe CP.'}, {'measure': 'Severe Vision Impairment', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if the corrected visual acuity in the better eye of less than 20/200; Otherwise, No.'}, {'measure': 'Severe Hearing Impairment', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if bilateral hearing loss occurred for which hearing aids or cochlear implants were warranted; Otherwise, No.'}], 'secondaryOutcomes': [{'measure': 'Survival to Discharge Without Severe Complications', 'timeFrame': 'Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as Yes if survived to discharge without severe morbidity, defined as bronchopulmonary dysplasia, retinopathy of prematurity (stage 3 or higher or requiring treatment), or serious brain abnormality; Otherwise, No.'}, {'measure': 'Bronchopulmonary Dysplasia, Diagnosed on the Basis of the Need for Supplemental Oxygen After a Standardized Oxygen Reduction Test at 36 Weeks of Postmenstrual Age', 'timeFrame': 'at 36 weeks postmenstrual age', 'description': 'This is measured as Yes if experienced bronchopulmonary dysplasia, diagnosed on the basis of the need for supplemental oxygen after a standardized oxygen reduction test at 36 weeks of postmenstrual age; Otherwise, No.'}, {'measure': 'Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received', 'timeFrame': 'Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as Yes if experienced Retinopathy of Prematurity (ROP) Stage \\>=3 or received treatment for that condition; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.'}, {'measure': 'Grade 3 or 4 Intraventricular Hemorrhage, Cystic Periventricular Leukomalacia, or Ventriculomegaly Diagnosed on Ultrasonographic Examination', 'timeFrame': 'Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as Yes if experienced Grade 3 or 4 intraventricularhemorrhage, cystic periventricular leukomalacia, or ventriculomegaly diagnosed on ultrasonographic examination; Otherwise, No.'}, {'measure': "Necrotizing Enterocolitis, Bell's Stage >=2", 'timeFrame': 'Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as Yes if experienced necrotizing enterocolitis (NEC), Bell\'s stage \\>=2; Otherwise, No. Higher scores of Bell\'s staging criteria denote a worse outcome, where "1" denotes suspect, "2" definite and "3" advanced NEC.'}, {'measure': 'Number of Transfusions Per Infant', 'timeFrame': 'Birth, up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age (PMA)', 'description': 'This is measured as the number of protocol compliant transfusions, clinically justified non-protocol transfusions and unjustified non-protocol transfusions (violations)'}, {'measure': 'Weight-for-age: Z-score', 'timeFrame': 'at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first', 'description': 'This is measured as the weight-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average weight-for-age, and negative scores denote less than average weight-for-age.'}, {'measure': 'Length-for-age: Z-score', 'timeFrame': 'at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first', 'description': 'This is measured as the length-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average length-for-age, and negative scores denote less than average length-for-age.'}, {'measure': 'Head Circumference-for-age: Z-score', 'timeFrame': 'at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first', 'description': 'This is measured as the head circumference-for-age Z-score at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first. The Z-score is determined using Olsen percentile curves, and is derived from a normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age.'}, {'measure': 'Postmenstrual Age at Final Trachael Extubation', 'timeFrame': 'at final trachael extubation, assessed from birth up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age', 'description': 'This is measured as the average postmenstrual age (in weeks) at final tracheal extubation in infants who were intubated.'}, {'measure': 'Postmenstrual Age at Final Caffeine Dose in Infants Who Received Caffeine Treatment', 'timeFrame': 'at final caffeine dose, assessed from birth up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age', 'description': 'This is measured as the average postmenstrual age (in weeks) at final caffeine dose in infants who received caffeine treatment.'}, {'measure': 'Length of Stay', 'timeFrame': 'at initial hospital discharge or at death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as the length of stay (in days) up to initial hospital discharge or death, whichever occurred first.'}, {'measure': 'Time to Full Enteral Feeding', 'timeFrame': 'at first full enteral feeding, assessed from birth up to initial hospital discharge or to death if it occurs earlier (a median of 97 days)', 'description': 'This is measured as the amount of days it took for full enteral feeding to occur.'}, {'measure': 'Severe Cerebral Palsy', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if Gross Motor Function Classification System (GMFCS) is levels IV or V; Otherwise, No. Higher values of the GMFCS are worse than lower values; a level of "I" denotes mild cerebral palsy (CP); level "II" or "III" moderate CP; level "IV" or "V" severe CP.'}, {'measure': 'Hydrocephalus Shunt', 'timeFrame': 'Initial hospital discharge to 22-26 months corrected age', 'description': 'This is measured as Yes if experienced Hydrocephalus shunt by follow-up; Otherwise, No.'}, {'measure': 'Microcephaly', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as a head circumference-for-age Z-score of less than -2; Otherwise, No. The Z-score is determined using WHO percentile curves, and is derived from a normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age.'}, {'measure': 'Seizure Disorder', 'timeFrame': 'Initial hospital discharge to 22-26 months corrected age', 'description': 'This is measured as Yes if experienced one or more seizures since discharge or of regular use of anticonvulsants or seizure medications; Otherwise, No.'}, {'measure': 'Respiratory Disease Necessitating Readmission Before Follow-up', 'timeFrame': 'Initial hospital discharge to 22-26 months corrected age', 'description': 'This is measured as Yes if obtained Respiratory disease necessitating readmission before follow-up; Otherwise, No.'}, {'measure': 'Composite Language Score Less Than 85', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite language score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.'}, {'measure': 'Composite Motor Score Less Than 85', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite motor score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.'}, {'measure': 'Composite Cognitive Score Less Than 70', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.'}, {'measure': 'Composite Language Score Less Than 70', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite language score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.'}, {'measure': 'Composite Motor Score Less Than 70', 'timeFrame': 'at 22-26 months corrected age', 'description': 'This is measured as Yes if scored less than 85 on the Bayley Scale of Infant and Toddler Development (BSID)-III composite motor score; Otherwise, No. Higher scores indicate better performance. Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NICHD Neonatal Research Network', 'Very Low Birth Weight (VLBW)', 'Extremely Low Birth Weight (ELBW)', 'Transfusions'], 'conditions': ['Infant, Newborn, Diseases', 'Infant, Extremely Low Birth Weight', 'Infant, Small for Gestational Age', 'Bronchopulmonary Dysplasia (BPD)', 'Anemia']}, 'referencesModule': {'references': [{'pmid': '40375228', 'type': 'DERIVED', 'citation': 'Conrad AL, DeMauro SB, Kirpalani H, Ziolkowski K, Hintz SR, Vohr BR, Watson V, Colaizy TT, Bell EF, Brumbaugh JE, Bann CM, Tan SM, Newman JE, Das A. The transfusion of prematures early school age follow-up (TOP 5): protocol for a longitudinal cohort study. BMC Pediatr. 2025 May 15;25(1):387. doi: 10.1186/s12887-025-05732-3.'}, {'pmid': '38700862', 'type': 'DERIVED', 'citation': 'Salas AA, Gunn E, Carlo WA, Bell EF, Das A, Josephson CD, Patel RM, Tan S, Kirpalani H; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Timing of Red Blood Cell Transfusions and Occurrence of Necrotizing Enterocolitis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e249643. doi: 10.1001/jamanetworkopen.2024.9643.'}, {'pmid': '37733345', 'type': 'DERIVED', 'citation': 'Chock VY, Kirpalani H, Bell EF, Tan S, Hintz SR, Ball MB, Smith E, Das A, Loggins YC, Sood BG, Chalak LF, Wyckoff MH, Kicklighter SD, Kennedy KA, Patel RM, Carlo WA, Johnson KJ, Watterberg KL, Sanchez PJ, Laptook AR, Seabrook RB, Cotten CM, Mancini T, Sokol GM, Ohls RK, Hibbs AM, Poindexter BB, Reynolds AM, DeMauro SB, Chawla S, Baserga M, Walsh MC, Higgins RD, Van Meurs KP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Tissue Oxygenation Changes After Transfusion and Outcomes in Preterm Infants: A Secondary Near-Infrared Spectroscopy Study of the Transfusion of Prematures Randomized Clinical Trial (TOP NIRS). JAMA Netw Open. 2023 Sep 5;6(9):e2334889. doi: 10.1001/jamanetworkopen.2023.34889.'}, {'pmid': '33382931', 'type': 'DERIVED', 'citation': "Kirpalani H, Bell EF, Hintz SR, Tan S, Schmidt B, Chaudhary AS, Johnson KJ, Crawford MM, Newman JE, Vohr BR, Carlo WA, D'Angio CT, Kennedy KA, Ohls RK, Poindexter BB, Schibler K, Whyte RK, Widness JA, Zupancic JAF, Wyckoff MH, Truog WE, Walsh MC, Chock VY, Laptook AR, Sokol GM, Yoder BA, Patel RM, Cotten CM, Carmen MF, Devaskar U, Chawla S, Seabrook R, Higgins RD, Das A; Eunice Kennedy Shriver NICHD Neonatal Research Network. Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants. N Engl J Med. 2020 Dec 31;383(27):2639-2651. doi: 10.1056/NEJMoa2020248."}], 'seeAlsoLinks': [{'url': 'http://neonatal.rti.org/', 'label': 'NICHD NRN Website'}, {'url': 'https://www.nichd.nih.gov/about/org/der/branches/ppb', 'label': 'NICHD Pregnancy \\& Perinatology Branch'}]}, 'descriptionModule': {'briefSummary': 'The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.', 'detailedDescription': 'Long-term outcomes of extremely low birth weight (ELBW) preterm infants, those weighing less than or equal to 1000 g at birth, are poor and pose a major health care burden. Virtually all of these infants are transfused, but at inconsistent hemoglobin (Hgb) thresholds.\n\nThe investigators propose in TOP to randomize infants less than or equal to 1000 g BW and gestational age at least 22 weeks but less than 29 weeks to receive red blood cell (RBC) transfusions according to one of two strategies of Hgb thresholds, either a high Hgb (liberal transfusion) or a low Hgb (restrictive transfusion) algorithm. It is currently unknown which transfusion strategy is superior. TOP is powered to demonstrate which strategy reduces the primary outcome of death or neurodisability in survivors at 22-26 months.\n\nA secondary study entitled "Effect of Blood Transfusion Practices on Cerebral and Somatic Oximetry", also known as the NIRS study, will determine differences in cerebral oxygenation and fractional tissue oxygen extraction with NIRS between high and low hemoglobin threshold groups during red blood cell transfusions. The investigators also propose to determine whether abnormal cerebral NIRS measures are a better predictor of NDI than hemoglobin alone and whether abnormal mesenteric NIRS measures are associated with the development of NEC within the 48 hours following a transfusion.\n\nA secondary study entitled "Economic Evaluation Ancillary to the Transfusion of Prematures Randomized Controlled Trial" will determine whether higher transfusion threshold will result in lower total costs to society over the first 22 to 26 corrected months of life and estimate the incremental cost-effectiveness ratio for survival without neurodevelopmental impairment, from the perspective of society, the third-party payer, and the family.\n\nExtended follow-up: Subjects will be seen for a follow-up visit at 5-6 years corrected age to assess neurological and functional outcomes at early school age based on neonatal transfusion threshold.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight less than or equal to 1000 grams.\n* Gestational age at least 22 weeks but less than 29 weeks\n* Admitted to the NICU within 48 hours of life\n\nExclusion Criteria:\n\n* Considered nonviable by the attending neonatologist\n* Cyanotic congenital heart disease\n* Parents opposed to the transfusion of blood\n* Parents with hemoglobinopathy or congenital anemia\n* In-utero fetal transfusion\n* Twin-to-twin transfusion syndrome\n* Isoimmune hemolytic disease\n* Lack of parental consent\n* Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for perioperative transfusion.\n* Prior blood transfusion on clinical grounds beyond the first 6 hours of life\n* Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course\n* Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment.\n* High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.'}, 'identificationModule': {'nctId': 'NCT01702805', 'acronym': 'TOP', 'briefTitle': 'Transfusion of Prematures Trial', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Neonatal Research Network'}, 'officialTitle': 'Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?', 'orgStudyIdInfo': {'id': 'NICHD-NRN-0050'}, 'secondaryIdInfos': [{'id': 'U01HL112776', 'link': 'https://reporter.nih.gov/quickSearch/U01HL112776', 'type': 'NIH'}, {'id': 'U01HL112748', 'link': 'https://reporter.nih.gov/quickSearch/U01HL112748', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Threshold Transfusion', 'description': "Transfusions will be administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group", 'interventionNames': ['Procedure: Restricted red cell transfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Threshold Transfusion', 'description': 'Transfusions will be administered using a higher threshold hemoglobin value.', 'interventionNames': ['Procedure: Liberal Cell Transfusion']}], 'interventions': [{'name': 'Liberal Cell Transfusion', 'type': 'PROCEDURE', 'armGroupLabels': ['High Threshold Transfusion']}, {'name': 'Restricted red cell transfusion', 'type': 'PROCEDURE', 'armGroupLabels': ['Low Threshold Transfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'RTI International', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Case Western Reserve University, Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Research Institute at Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univeristy of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University, Women & Infants Hospital of Rhode Island', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Michele C Walsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Case Western Reserve University, Rainbow Babies and Children's Hospital"}, {'name': 'Abhik Das, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International'}, {'name': 'Beena Sood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}, {'name': 'Abbot R Laptook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University, Women & Infants Hospital of Rhode Island'}, {'name': 'Michael Cotten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Ravi Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Greg Sokol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Krisa P Van Meurs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Brenda Poindexter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Waldemar A Carlo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Kristi L Watterberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}, {'name': 'Myra Wyckoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas, Southwestern Medical Center at Dallas'}, {'name': 'Kathleen A Kennedy, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': "Carl T D'Angio, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Pablo Sanchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Research Institute at Nationwide Children's Hospital"}, {'name': 'William Truog, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}, {'name': 'Uday Devaskar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Haresh M Kirpalani, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Bradley Yoder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Neonatal Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}