Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-01 @ 2:41 AM
Study NCT ID:
NCT00369005
Status:
COMPLETED
Last Update Posted:
2006-08-29
First Post:
2006-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D007969', 'term': 'Leukomalacia, Periventricular'}, {'id': 'D001049', 'term': 'Apnea'}], '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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004678', 'term': 'Encephalomalacia'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '1999-06'}, 'lastUpdateSubmitDate': '2006-08-28', 'studyFirstSubmitDate': '2006-08-28', 'studyFirstSubmitQcDate': '2006-08-28', 'lastUpdatePostDateStruct': {'date': '2006-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of red blood cell transfusions'}, {'measure': 'number of transfusion donors'}], 'secondaryOutcomes': [{'measure': 'survival to discharge'}, {'measure': 'patent ductus arteriosus'}, {'measure': 'germinal matrix or intraventricular hemorrhage'}, {'measure': 'periventricular leukomalacia'}, {'measure': 'retinopathy of prematurity'}, {'measure': 'bronchopulmonary dysplasia'}, {'measure': 'duration of assisted ventilation'}, {'measure': 'duration of supplemental oxygen therapy'}, {'measure': 'number and frequency of all apnea episodes'}, {'measure': 'number and frequency of apnea episodes requiring tactile stimulation'}, {'measure': 'number and frequency of apnea episodes requiring assisted ventilation'}, {'measure': 'number and frequency of apnea episodes during the 24 hours before and after each transfusion'}, {'measure': 'time to regain birth weight'}, {'measure': 'time to double birth weight'}, {'measure': 'length of hospitalization'}, {'measure': 'hemoglobin'}, {'measure': 'hematocrit'}, {'measure': 'reticulocyte count'}, {'measure': 'oxygen saturation (pulse oximetry)'}, {'measure': 'cardiac output (echocardiography)'}, {'measure': 'blood lactic acid'}, {'measure': 'plasma erythropoietin'}, {'measure': 'serum ferritin'}]}, 'conditionsModule': {'keywords': ['Transfusions', 'Erythrocyte', 'Anemia', 'Brain', 'Infant, Premature'], 'conditions': ['Infant, Premature', 'Anemia', 'Intracranial Hemorrhages', 'Leukomalacia, Periventricular', 'Apnea']}, 'referencesModule': {'references': [{'pmid': '15930233', 'type': 'RESULT', 'citation': 'Bell EF, Strauss RG, Widness JA, Mahoney LT, Mock DM, Seward VJ, Cress GA, Johnson KJ, Kromer IJ, Zimmerman MB. Randomized trial of liberal versus restrictive guidelines for red blood cell transfusion in preterm infants. Pediatrics. 2005 Jun;115(6):1685-91. doi: 10.1542/peds.2004-1884.'}, {'pmid': '21199970', 'type': 'DERIVED', 'citation': 'Nopoulos PC, Conrad AL, Bell EF, Strauss RG, Widness JA, Magnotta VA, Zimmerman MB, Georgieff MK, Lindgren SD, Richman LC. Long-term outcome of brain structure in premature infants: effects of liberal vs restricted red blood cell transfusions. Arch Pediatr Adolesc Med. 2011 May;165(5):443-50. doi: 10.1001/archpediatrics.2010.269. Epub 2011 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine whether restrictive guidelines for red blood cell (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse consequences.', 'detailedDescription': 'Design, Setting, and Patients. We enrolled 100 hospitalized preterm infants with birth weights 500 to 1300 g into a randomized clinical trial comparing two levels of hematocrit threshold for RBC transfusion.\n\nIntervention. The infants were randomly assigned to either the liberal or the restrictive transfusion group. For each group, transfusions were given only when the hematocrit fell below the assigned value. In each group, the transfusion thresholds decreased with improving clinical status.\n\nMain Outcome Measures. We recorded the number of transfusions, the number of donor exposures, and various clinical and physiological outcomes.\n\nResults. Infants in the liberally transfused group received more RBC transfusions, mean 5.2 (SD 4.5) vs 3.3 (SD 2.9) in the restrictive transfusion group (P=0.025). However, the number of donors to whom the infants were exposed was not significantly different, mean 2.8 (SD 2.5) vs 2.2 (SD 2.0). There was no difference between the groups in the percentage of infants who avoided transfusions altogether, 12% in the liberal transfusion group vs 10% in the restrictive group. Infants in the restrictive group were more likely to have intraparenchymal brain hemorrhage or periventricular leukomalacia (P=0.012), and they had more frequent episodes of apnea (P=0.004), including both mild and severe episodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Weeks', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infant\n* Birth weight 500-1300 grams\n\nExclusion Criteria:\n\n* Alloimmune hemolytic disease\n* Congenital heart disease\n* Other major birth defect requiring surgery\n* Chromosomal abnormality\n* Thought to be facing imminent death\n* Parental philosophical or religious objections to transfusion\n* More than 2 transfusions before enrollment\n* Participation in other research study with potential impact on this study'}, 'identificationModule': {'nctId': 'NCT00369005', 'briefTitle': 'Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants', 'orgStudyIdInfo': {'id': 'IowaBell001'}, 'secondaryIdInfos': [{'id': 'P01HL046925', 'link': 'https://reporter.nih.gov/quickSearch/P01HL046925', 'type': 'NIH'}, {'id': 'M01RR000059', 'link': 'https://reporter.nih.gov/quickSearch/M01RR000059', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Red blood cell transfusion guidelines', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Edward F. Bell, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}]}}}