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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)
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
Sex
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
1/02/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2005
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/ct2/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