Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT00369005
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00369005
Study Brief:
Protocol Section:
NCT00369005