Premature Infants in Need of Transfusion (PINT)

Completed · Phase 3

Conditions studied: Anemia of Prematurity

In brief

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.

Key facts

Study ID

NCT00182390

Run by

McMaster University

People needed

424

Starts

2001-02-01

Expected to finish

2005-11-01

Last updated by the study team

2015-09-24

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• birth weight <1000g
• postnatal age <48 hours
• no transfusion beyond first 6 hours of life
• estimated gestational age of 30 completed weeks or less

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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