Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants
Primary Purpose
Infant, Premature, Anemia, Intracranial Hemorrhages
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Red blood cell transfusion guidelines
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Premature focused on measuring Transfusions, Erythrocyte, Anemia, Brain, Infant, Premature
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
Sites / Locations
Outcomes
Primary Outcome Measures
number of red blood cell transfusions
number of transfusion donors
Secondary Outcome Measures
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
hemoglobin
hematocrit
reticulocyte count
oxygen saturation (pulse oximetry)
cardiac output (echocardiography)
blood lactic acid
plasma erythropoietin
serum ferritin
Full Information
NCT ID
NCT00369005
First Posted
August 28, 2006
Last Updated
August 28, 2006
Sponsor
University of Iowa
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00369005
Brief Title
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
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
December 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Iowa
Collaborators
National Institutes of Health (NIH)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Anemia, Intracranial Hemorrhages, Leukomalacia, Periventricular, Apnea
Keywords
Transfusions, Erythrocyte, Anemia, Brain, Infant, Premature
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Red blood cell transfusion guidelines
Primary Outcome Measure Information:
Title
number of red blood cell transfusions
Title
number of transfusion donors
Secondary Outcome Measure Information:
Title
survival to discharge
Title
patent ductus arteriosus
Title
germinal matrix or intraventricular hemorrhage
Title
periventricular leukomalacia
Title
retinopathy of prematurity
Title
bronchopulmonary dysplasia
Title
duration of assisted ventilation
Title
duration of supplemental oxygen therapy
Title
number and frequency of all apnea episodes
Title
number and frequency of apnea episodes requiring tactile stimulation
Title
number and frequency of apnea episodes requiring assisted ventilation
Title
number and frequency of apnea episodes during the 24 hours before and after each transfusion
Title
time to regain birth weight
Title
time to double birth weight
Title
length of hospitalization
Title
hemoglobin
Title
hematocrit
Title
reticulocyte count
Title
oxygen saturation (pulse oximetry)
Title
cardiac output (echocardiography)
Title
blood lactic acid
Title
plasma erythropoietin
Title
serum ferritin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward F. Bell, M.D.
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
15930233
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.
Results Reference
result
PubMed Identifier
21199970
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.
Results Reference
derived
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Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants
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