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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
Scientific title
A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
Secondary ID [1] 0 0
CIHR MCT-41549
Secondary ID [2] 0 0
CTMG-2001-PINT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia of Prematurity 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Red blood cell transfusion

Treatment: Surgery: Red blood cell transfusion


Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)
Timepoint [1] 0 0
neonatal phase
Primary outcome [2] 0 0
Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)
Timepoint [2] 0 0
follow-up phase 18 months corrected age
Secondary outcome [1] 0 0
growth in weight and head circumference
Timepoint [1] 0 0
neonatal phase
Secondary outcome [2] 0 0
time to extubation
Timepoint [2] 0 0
neonatal phase
Secondary outcome [3] 0 0
time on oxygen
Timepoint [3] 0 0
neonatal phase
Secondary outcome [4] 0 0
length of hospital stay until discharge home
Timepoint [4] 0 0
neonatal phase
Secondary outcome [5] 0 0
confirmed necrotizing enterocolitis
Timepoint [5] 0 0
neonatal phase
Secondary outcome [6] 0 0
apnea requiring treatment
Timepoint [6] 0 0
neonatal phase
Secondary outcome [7] 0 0
culture-proven infections
Timepoint [7] 0 0
neonatal phase
Secondary outcome [8] 0 0
use of post-natal steroids
Timepoint [8] 0 0
neonatal phase
Secondary outcome [9] 0 0
mean levels of hemoglobin
Timepoint [9] 0 0
neonatal phase
Secondary outcome [10] 0 0
number of transfusions
Timepoint [10] 0 0
neonatal phase
Secondary outcome [11] 0 0
number of donor exposures
Timepoint [11] 0 0
neonatal phase
Secondary outcome [12] 0 0
serum ferritin levels
Timepoint [12] 0 0
neonatal phase
Secondary outcome [13] 0 0
milder forms of cerebral palsy
Timepoint [13] 0 0
follow-up phase 18 months corrected age
Secondary outcome [14] 0 0
milder neurologic disorder
Timepoint [14] 0 0
follow-up phase 18 months corrected age
Secondary outcome [15] 0 0
personal and social functional capabilities
Timepoint [15] 0 0
follow-up phase 18 months corrected age
Secondary outcome [16] 0 0
hydrocephalus requiring a shunt
Timepoint [16] 0 0
follow-up phase 18 months corrected age
Secondary outcome [17] 0 0
seizure disorder
Timepoint [17] 0 0
follow-up phase 18 months corrected age
Secondary outcome [18] 0 0
respiratory disease
Timepoint [18] 0 0
follow-up phase 18 months corrected age
Secondary outcome [19] 0 0
iron nutritional status
Timepoint [19] 0 0
follow-up phase 18 months corrected age
Secondary outcome [20] 0 0
physical growth including head size
Timepoint [20] 0 0
follow-up phase 18 months corrected age

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
Minimum age
No limit
Maximum age
48 Hours
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Women's Hospital - Melbourne
Recruitment hospital [2] 0 0
Mercy Hospital for Women - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00182390
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Haresh Kirpalani, MD, MSc
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications