We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

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.
ClinicalTrials.gov Identifier: NCT00369005
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : August 29, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Infant, Premature Anemia Intracranial Hemorrhages Leukomalacia, Periventricular Apnea Procedure: Red blood cell transfusion guidelines

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants
Study Start Date : December 1992
Estimated Study Completion Date : June 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. number of red blood cell transfusions
  2. number of transfusion donors

Secondary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369005


Sponsors and Collaborators
University of Iowa
National Institutes of Health (NIH)
Investigators
Principal Investigator: Edward F. Bell, M.D. University of Iowa
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00369005     History of Changes
Other Study ID Numbers: IowaBell001
P01HL046925 ( U.S. NIH Grant/Contract )
M01RR000059 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: August 29, 2006
Last Verified: August 2006

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

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