Clinical trial NCT00369005: Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants
Official title: Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Anemia
Intracranial Hemorrhages
Leukomalacia, Periventricular
Apnea
Keywords: Transfusions
Erythrocyte
Anemia
Brain
Infant, Premature
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: number of red blood cell transfusions
measure: number of transfusion donors
Secondary outcomes:
measure: survival to discharge
measure: patent ductus arteriosus
measure: germinal matrix or intraventricular hemorrhage
measure: periventricular leukomalacia
measure: retinopathy of prematurity
measure: bronchopulmonary dysplasia
measure: duration of assisted ventilation
measure: duration of supplemental oxygen therapy
measure: number and frequency of all apnea episodes
measure: number and frequency of apnea episodes requiring tactile stimulation
measure: number and frequency of apnea episodes requiring assisted ventilation
measure: number and frequency of apnea episodes during the 24 hours before and after each transfusion
measure: time to regain birth weight
measure: time to double birth weight
measure: length of hospitalization
measure: hemoglobin
measure: hematocrit
measure: reticulocyte count
measure: oxygen saturation (pulse oximetry)
measure: cardiac output (echocardiography)
measure: blood lactic acid
measure: plasma erythropoietin
measure: serum ferritin
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Edward F. Bell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.