Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

August 28, 2006 updated by: University of Iowa

Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants

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.

Study Overview

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 Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
number of red blood cell transfusions
number of transfusion donors

Secondary Outcome Measures

Outcome Measure
hemoglobin
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
hematocrit
reticulocyte count
oxygen saturation (pulse oximetry)
cardiac output (echocardiography)
blood lactic acid
plasma erythropoietin
serum ferritin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Edward F. Bell, M.D., University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1992

Study Completion

June 1, 1999

Study Registration Dates

First Submitted

August 28, 2006

First Submitted That Met QC Criteria

August 28, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Estimate)

August 29, 2006

Last Update Submitted That Met QC Criteria

August 28, 2006

Last Verified

August 1, 2006

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Apnea

Clinical Trials on Red blood cell transfusion guidelines

Subscribe