Premature Infants in Need of Transfusion (PINT)

Anemia of Prematurity Clinical Trial

Official title:

A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182390
• Other study ID #: CTMG-2001-PINT
• Secondary ID: CIHR MCT-41549CI
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 22, 2015
• Start date: February 2001
• Est. completion date: November 2005

Study information

• Verified date: September 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: November 2005
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia of Prematurity
• Anemia, Neonatal
• Infant, Premature, Diseases
• Premature Birth

Intervention

Procedure:
• Red blood cell transfusion

Locations

Country	Name	City	State
Australia	Mercy Hospital for Women	Melbourne	Victoria
Australia	Royal Women's Hospital	Melbourne	Victoria
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster University	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Sunnybrook & Women's College Health Science Centre	Toronto	Ontario
United States	Albany Medical Center	Albany	New York
United States	Brooklyn Hospital Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

References & Publications (2)

Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) — View Citation

Whyte RK, Kirpalani H, Asztalos EV, Andersen C, Blajchman M, Heddle N, LaCorte M, Robertson CM, Clarke MC, Vincer MJ, Doyle LW, Roberts RS; PINTOS Study Group. Neurodevelopmental outcome of extremely low birth weight infants randomly assigned to restricti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)		neonatal phase	No
Primary	Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)		follow-up phase 18 months corrected age	No
Secondary	growth in weight and head circumference		neonatal phase	No
Secondary	time to extubation		neonatal phase	No
Secondary	time on oxygen		neonatal phase	No
Secondary	length of hospital stay until discharge home		neonatal phase	No
Secondary	confirmed necrotizing enterocolitis		neonatal phase	No
Secondary	apnea requiring treatment		neonatal phase	No
Secondary	culture-proven infections		neonatal phase	No
Secondary	use of post-natal steroids		neonatal phase	No
Secondary	mean levels of hemoglobin		neonatal phase	No
Secondary	number of transfusions		neonatal phase	No
Secondary	number of donor exposures		neonatal phase	No
Secondary	serum ferritin levels		neonatal phase	No
Secondary	milder forms of cerebral palsy		follow-up phase 18 months corrected age	No
Secondary	milder neurologic disorder		follow-up phase 18 months corrected age	No
Secondary	personal and social functional capabilities		follow-up phase 18 months corrected age	No
Secondary	hydrocephalus requiring a shunt		follow-up phase 18 months corrected age	No
Secondary	seizure disorder		follow-up phase 18 months corrected age	No
Secondary	respiratory disease		follow-up phase 18 months corrected age	No
Secondary	iron nutritional status		follow-up phase 18 months corrected age	No
Secondary	physical growth including head size		follow-up phase 18 months corrected age	No