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Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00369005
First received: August 28, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Infant, Premature
Anemia
Intracranial Hemorrhages
Leukomalacia, Periventricular
Apnea
Procedure: Red blood cell transfusion guidelines

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • number of red blood cell transfusions
  • number of transfusion donors

Secondary Outcome Measures:
  • 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
  • hematocrit
  • reticulocyte count
  • oxygen saturation (pulse oximetry)
  • cardiac output (echocardiography)
  • blood lactic acid
  • plasma erythropoietin
  • serum ferritin

Estimated Enrollment: 100
Study Start Date: December 1992
Estimated Study Completion Date: June 1999
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.

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369005

Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Edward F. Bell, M.D. University of Iowa
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00369005     History of Changes
Other Study ID Numbers: IowaBell001, P01 HL46925, M01 RR00059
Study First Received: August 28, 2006
Last Updated: August 28, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Transfusions
Erythrocyte
Anemia
Brain
Infant, Premature

Additional relevant MeSH terms:
Leukomalacia, Periventricular
Hemorrhage
Intracranial Hemorrhages
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Encephalomalacia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014