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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
number of red blood cell transfusions
number of transfusion donors
survival to discharge
patent ductus arteriosus
germinal matrix or intraventricular hemorrhage
periventricular leukomalacia
retinopathy of prematurity
bronchopulmonary dysplasia
duration of assisted ventilation
duration of supplemental oxygen therapy
number and frequency of all apnea episodes
number and frequency of apnea episodes requiring tactile stimulation
number and frequency of apnea episodes requiring assisted ventilation
number and frequency of apnea episodes during the 24 hours before and after each transfusion
time to regain birth weight
time to double birth weight
length of hospitalization
hemoglobin
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hematocrit
reticulocyte count
oxygen saturation (pulse oximetry)
cardiac output (echocardiography)
blood lactic acid
plasma erythropoietin
serum ferritin