Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Iowa National Institutes of Health (NIH) |
---|---|
Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00369005 |
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.
Condition | Intervention |
---|---|
Infant, Premature Anemia Intracranial Hemorrhages Leukomalacia, Periventricular Apnea |
Procedure: Red blood cell transfusion guidelines |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants |
Estimated Enrollment: | 100 |
Study Start Date: | December 1992 |
Estimated Study Completion Date: | June 1999 |
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.
Intervention. 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.
Main Outcome Measures. We recorded the number of transfusions, the number of donor exposures, and various clinical and physiological outcomes.
Results. 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.
Ages Eligible for Study: | up to 2 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | IowaBell001, P01 HL46925, M01 RR00059 |
Study First Received: | August 28, 2006 |
Last Updated: | August 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00369005 History of Changes |
Health Authority: | United States: Institutional Review Board |
Transfusions Erythrocyte Anemia Brain Infant, Premature |
Apnea Hematologic Diseases Anemia Vascular Diseases Central Nervous System Diseases Infant, Premature, Diseases Intracranial Hemorrhages |
Hemorrhage Brain Diseases Cerebrovascular Disorders Leukomalacia, Periventricular Encephalomalacia Leukomalacia Infant, Newborn, Diseases |
Hematologic Diseases Nervous System Diseases Anemia Vascular Diseases Central Nervous System Diseases Infant, Premature, Diseases Intracranial Hemorrhages Hemorrhage |
Brain Diseases Cerebrovascular Disorders Leukomalacia, Periventricular Pathologic Processes Encephalomalacia Infant, Newborn, Diseases Cardiovascular Diseases |