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Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00369005
First Posted: August 29, 2006
Last Update Posted: August 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Iowa
August 28, 2006
August 29, 2006
August 29, 2006
December 1992
Not Provided
  • number of red blood cell transfusions
  • number of transfusion donors
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Infant, Premature
  • Anemia
  • Intracranial Hemorrhages
  • Leukomalacia, Periventricular
  • Apnea
Procedure: Red blood cell transfusion guidelines
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 1999
Not Provided

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
Sexes Eligible for Study: All
up to 2 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00369005
IowaBell001
P01HL046925 ( U.S. NIH Grant/Contract )
M01RR000059 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Not Provided
University of Iowa
National Institutes of Health (NIH)
Principal Investigator: Edward F. Bell, M.D. University of Iowa
University of Iowa
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP