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Completed

NCT Number: NCT00369005

Liberal Versus Restrictive Transfusion Guidelines for 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red blood cell transfusion guidelines

Procedure

Primary outcomes

  1. number of red blood cell transfusions

  2. number of transfusion donors

Secondary outcomes

  1. survival to discharge

  2. patent ductus arteriosus

  3. germinal matrix or intraventricular hemorrhage

  4. periventricular leukomalacia

  5. retinopathy of prematurity

  6. bronchopulmonary dysplasia

  7. duration of assisted ventilation

  8. duration of supplemental oxygen therapy

  9. number and frequency of all apnea episodes

  10. number and frequency of apnea episodes requiring tactile stimulation

  11. number and frequency of apnea episodes requiring assisted ventilation

  12. number and frequency of apnea episodes during the 24 hours before and after each transfusion

  13. time to regain birth weight

  14. time to double birth weight

  15. length of hospitalization

  16. hemoglobin

  17. hematocrit

  18. reticulocyte count

  19. oxygen saturation (pulse oximetry)

  20. cardiac output (echocardiography)

  21. blood lactic acid

  22. plasma erythropoietin

  23. serum ferritin

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
1992
Study completion
1999
First posted
Aug 29, 2006
Registry last updated
Aug 29, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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