ClinicalTrials.Veeva

Menu

Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

University of Iowa logo

University of Iowa

Status

Completed

Conditions

Anemia
Apnea
Intracranial Hemorrhages
Infant, Premature
Leukomalacia, Periventricular

Treatments

Procedure: Red blood cell transfusion guidelines

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00369005
M01RR000059 (U.S. NIH Grant/Contract)
P01HL046925 (U.S. NIH Grant/Contract)
IowaBell001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 2 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems