Premature Infants in Need of Transfusion (PINT)

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

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.

ELBW premature infants, neonatal transfusion, bronchopulmonary dysplasia, periventricular leukomalacia, ventriculomegaly, retinopathy of prematurity

Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)

Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)

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

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) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr. 2006 Sep;149(3):301-307. doi: 10.1016/j.jpeds.2006.05.011.

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 restrictive or liberal hemoglobin thresholds for blood transfusion. Pediatrics. 2009 Jan;123(1):207-13. doi: 10.1542/peds.2008-0338.