Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369005
• Other study ID #: IowaBell001
• Secondary ID: P01HL046925M01RR
• Status: Completed
• Phase: N/A
• First received: August 28, 2006
• Last updated: August 28, 2006
• Start date: December 1992
• Est. completion date: June 1999

Study information

• Verified date: August 2006
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Apnea
• Infant, Premature
• Intracranial Hemorrhages
• Leukomalacia, Periventricular

Intervention

Procedure:
• Red blood cell transfusion guidelines

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Institutes of Health (NIH)

References & Publications (1)

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):1685-9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of red blood cell transfusions
Primary	number of transfusion donors
Secondary	survival to discharge
Secondary	patent ductus arteriosus
Secondary	germinal matrix or intraventricular hemorrhage
Secondary	periventricular leukomalacia
Secondary	retinopathy of prematurity
Secondary	bronchopulmonary dysplasia
Secondary	duration of assisted ventilation
Secondary	duration of supplemental oxygen therapy
Secondary	number and frequency of all apnea episodes
Secondary	number and frequency of apnea episodes requiring tactile stimulation
Secondary	number and frequency of apnea episodes requiring assisted ventilation
Secondary	number and frequency of apnea episodes during the 24 hours before and after each transfusion
Secondary	time to regain birth weight
Secondary	time to double birth weight
Secondary	length of hospitalization
Secondary	hemoglobin
Secondary	hematocrit
Secondary	reticulocyte count
Secondary	oxygen saturation (pulse oximetry)
Secondary	cardiac output (echocardiography)
Secondary	blood lactic acid
Secondary	plasma erythropoietin
Secondary	serum ferritin