Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

Not Applicable

Completed

• Conditions: Apnea; Infant, Premature; Anemia; Leukomalacia, Periventricular; Intracranial Hemorrhages

• Registration Number: NCT00369005
• Lead Sponsor: University of Iowa

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 Timeline

• Study Start: 1992-12
• Study Completion: 1999-06
• Status Verified: 2006-08
• Study First Submitted: 2006-08-28
• Study First Submitted QC: 2006-08-28
• Last Update Submitted: 2006-08-28
• Study First Posted: 2006-08-29
• Last Update Posted: 2006-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
number of red blood cell transfusions
number of transfusion donors

Secondary Outcome Measures

Name	Time	Method
reticulocyte count
survival to discharge
time to double birth weight
oxygen saturation (pulse oximetry)
cardiac output (echocardiography)
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