Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Iowa
- Enrollment
- 100
- Primary Endpoint
- number of red blood cell transfusions
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 2 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm infant
- •Birth weight 500-1300 grams
Exclusion Criteria
- •Alloimmune hemolytic disease
- •Congenital heart disease
- •Other major birth defect requiring surgery
- •Chromosomal abnormality
- •Thought to be facing imminent death
- •Parental philosophical or religious objections to transfusion
- •More than 2 transfusions before enrollment
- •Participation in other research study with potential impact on this study
Outcomes
Primary Outcomes
number of red blood cell transfusions
number of transfusion donors
Secondary Outcomes
- time to double birth weight
- oxygen saturation (pulse oximetry)
- cardiac output (echocardiography)
- survival to discharge
- bronchopulmonary dysplasia
- retinopathy of prematurity
- blood lactic acid
- serum ferritin
- periventricular leukomalacia
- number and frequency of apnea episodes requiring tactile stimulation
- number and frequency of all apnea episodes
- number and frequency of apnea episodes requiring assisted ventilation
- hemoglobin
- plasma erythropoietin
- patent ductus arteriosus
- germinal matrix or intraventricular hemorrhage
- time to regain birth weight
- hematocrit
- duration of assisted ventilation
- duration of supplemental oxygen therapy
- number and frequency of apnea episodes during the 24 hours before and after each transfusion
- length of hospitalization
- reticulocyte count