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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
University of Iowa
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature focused on measuring Transfusions, Erythrocyte, Anemia, Brain, Infant, Premature

Eligibility Criteria

0 Years - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 28, 2006
    Last Updated
    August 28, 2006
    Sponsor
    University of Iowa
    Collaborators
    National Institutes of Health (NIH)
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    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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