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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00182390
Registration number
NCT00182390
Ethics application status
Date submitted
13/09/2005
Date registered
16/09/2005
Date last updated
24/09/2015
Titles & IDs
Public title
Premature Infants in Need of Transfusion (PINT)
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Scientific title
A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
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Secondary ID [1]
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CIHR MCT-41549
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Secondary ID [2]
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CTMG-2001-PINT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anemia of Prematurity
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Condition category
Condition code
Reproductive Health and Childbirth
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Complications of newborn
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Red blood cell transfusion
Treatment: Surgery: Red blood cell transfusion
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)
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Assessment method [1]
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Timepoint [1]
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neonatal phase
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Primary outcome [2]
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Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)
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Assessment method [2]
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Timepoint [2]
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follow-up phase 18 months corrected age
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Secondary outcome [1]
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growth in weight and head circumference
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Assessment method [1]
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Timepoint [1]
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neonatal phase
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Secondary outcome [2]
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time to extubation
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Assessment method [2]
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Timepoint [2]
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neonatal phase
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Secondary outcome [3]
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time on oxygen
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Assessment method [3]
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Timepoint [3]
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neonatal phase
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Secondary outcome [4]
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length of hospital stay until discharge home
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Assessment method [4]
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Timepoint [4]
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neonatal phase
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Secondary outcome [5]
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confirmed necrotizing enterocolitis
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Assessment method [5]
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Timepoint [5]
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neonatal phase
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Secondary outcome [6]
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apnea requiring treatment
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Assessment method [6]
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Timepoint [6]
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neonatal phase
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Secondary outcome [7]
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culture-proven infections
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Assessment method [7]
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Timepoint [7]
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neonatal phase
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Secondary outcome [8]
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use of post-natal steroids
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Assessment method [8]
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Timepoint [8]
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neonatal phase
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Secondary outcome [9]
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mean levels of hemoglobin
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Assessment method [9]
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Timepoint [9]
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neonatal phase
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Secondary outcome [10]
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number of transfusions
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Assessment method [10]
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Timepoint [10]
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neonatal phase
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Secondary outcome [11]
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number of donor exposures
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Assessment method [11]
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Timepoint [11]
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neonatal phase
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Secondary outcome [12]
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serum ferritin levels
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Assessment method [12]
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Timepoint [12]
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neonatal phase
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Secondary outcome [13]
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milder forms of cerebral palsy
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Assessment method [13]
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Timepoint [13]
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follow-up phase 18 months corrected age
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Secondary outcome [14]
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milder neurologic disorder
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Assessment method [14]
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Timepoint [14]
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follow-up phase 18 months corrected age
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Secondary outcome [15]
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personal and social functional capabilities
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Assessment method [15]
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Timepoint [15]
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follow-up phase 18 months corrected age
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Secondary outcome [16]
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hydrocephalus requiring a shunt
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Assessment method [16]
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Timepoint [16]
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follow-up phase 18 months corrected age
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Secondary outcome [17]
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seizure disorder
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Assessment method [17]
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Timepoint [17]
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follow-up phase 18 months corrected age
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Secondary outcome [18]
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respiratory disease
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Assessment method [18]
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Timepoint [18]
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follow-up phase 18 months corrected age
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Secondary outcome [19]
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iron nutritional status
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Assessment method [19]
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Timepoint [19]
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follow-up phase 18 months corrected age
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Secondary outcome [20]
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physical growth including head size
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Assessment method [20]
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Timepoint [20]
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follow-up phase 18 months corrected age
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Eligibility
Key inclusion criteria
- birth weight <1000g
- postnatal age <48 hours
- no transfusion beyond first 6 hours of life
- estimated gestational age of 30 completed weeks or less
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Minimum age
No limit
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Maximum age
48
Hours
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- infant considered non-viable by attending physician
- infant has cyanotic congenital heart disease
- infant's parents known to be opposed to blood transfusion
- either parent has hemoglobinopathies or congenital anemias
- infant has hemolytic disease
- infant has severe acute hemorrhage, severe shock, severe sepsis with coagulopathy or
requires peri-operative transfusion
- prior treatment with or intention to treat with erythropoietin
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2005
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Women's Hospital - Melbourne
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Recruitment hospital [2]
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Mercy Hospital for Women - Melbourne
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Recruitment postcode(s) [1]
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3053 - Melbourne
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Recruitment postcode(s) [2]
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3084 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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Canada
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State/province [2]
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Alberta
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Country [3]
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Canada
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State/province [3]
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Nova Scotia
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Country [4]
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Canada
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State/province [4]
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Ontario
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Country [5]
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Canada
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State/province [5]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight
(ELBW) infants is associated with a lower rate of survival without severe morbidity (defined
as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular
leukomalacia/ventriculomegaly).
Primary Objective: To determine whether either a liberal or more restrictive threshold of
hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either
a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.
Follow-up at a corrected age of 18 months represents a conventional age at which to first
assess neurodevelopmental outcomes, and to predict long-term outcomes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00182390
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Haresh Kirpalani, MD, MSc
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Address
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McMaster University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00182390
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