Infant, PrematureNCT00369005
Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants
A study testing Red blood cell transfusion guidelines in people with Infant, Premature and Anemia, run by University of Iowa.
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. Read more about this study
- Who is it for?
- Ages 0 years to 2 weeks
- Conditions the study is for
- Infant, Premature, Anemia, Intracranial Hemorrhages
- What is being tested?
- Red blood cell transfusion guidelines
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 1992to Jun 1999
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant
- Birth weight 500-1300 grams
Who cannot join
- 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
About this study
Official title: Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants
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.
Read the 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.
- Being tested
- Red blood cell transfusion guidelines
- Keywords
- Transfusions, Erythrocyte, Anemia, Brain, Infant, Premature
- Medical subject headings
- Premature Birth, Anemia, Intracranial Hemorrhages, Leukomalacia, Periventricular, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusion guidelinesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
number of red blood cell transfusions
number of transfusion donors
Secondary outcomes (23)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startDec 1992
- Study completionJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Edward F. Bell, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369005
- Sponsor's protocol ID
- IowaBell001
- Other IDs
- P01HL046925, M01RR000059
- Status last verified
- Aug 2006
- First submitted
- 28 Aug 2006
- Last updated
- 29 Aug 2006
- Results posted
- No
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.
PubMed 15930233Nopoulos 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.
PubMed 21199970
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Liberal Versus Restrictive Guidelines for Red Blood Cell Transfusion in Preterm Infants
- ClinicalTrials.gov ID
- NCT00369005
- Acronym / sponsor ID
- IowaBell001
- Keywords
- Transfusions, Erythrocyte, Anemia, Brain, Infant, Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Dec 1992
- Study completion
- Jun 1999
- First posted
- 29 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infant
- Birth weight 500-1300 grams
Key exclusion criteria (8 listed)
- Alloimmune hemolytic disease
- Congenital heart disease
- Other major birth defect requiring surgery
- Chromosomal abnormality
- Thought to be facing imminent death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusion guidelines | Procedure or surgery | – |
Primary outcome
number of red blood cell transfusions
number of transfusion donors
23 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2006.
- Results publication: PubMed 15930233Bell 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.
- Derived from this study: PubMed 21199970Nopoulos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward F. Bell, M.D. principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A study testing Red blood cell transfusion guidelines in people with Infant, Premature and Anemia, run by University of Iowa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of red blood cell transfusions. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00369005, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2006.