- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00369005
Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants
Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants
Study Overview
Status
Intervention / Treatment
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
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Edward F. Bell, M.D., University of Iowa
Publications and helpful links
General Publications
- Bell EF, Strauss RG, Widness JA, Mahoney LT, Mock DM, Seward VJ, Cress GA, Johnson KJ, Kromer IJ, Zimmerman MB. Randomized trial of liberal versus restrictive guidelines for red blood cell transfusion in preterm infants. Pediatrics. 2005 Jun;115(6):1685-91. doi: 10.1542/peds.2004-1884.
- Nopoulos PC, Conrad AL, Bell EF, Strauss RG, Widness JA, Magnotta VA, Zimmerman MB, Georgieff MK, Lindgren SD, Richman LC. Long-term outcome of brain structure in premature infants: effects of liberal vs restricted red blood cell transfusions. Arch Pediatr Adolesc Med. 2011 May;165(5):443-50. doi: 10.1001/archpediatrics.2010.269. Epub 2011 Jan 3.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IowaBell001
- P01HL046925 (U.S. NIH Grant/Contract)
- M01RR000059 (U.S. NIH Grant/Contract)
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.
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