Premature Infants in Need of Transfusion (PINT)

McMaster University424 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

424

Conditions

Anemia of Prematurity

Interventions

Eligibility

Sex: ALLMax age: 48 Hours

Medical Language ↔ Plain English

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

Locations (10)

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

Outcomes

Primary Outcomes

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

Time frame: neonatal phase

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

Time frame: follow-up phase 18 months corrected age

Secondary Outcomes

growth in weight and head circumference

Time frame: neonatal phase

time to extubation

Time frame: neonatal phase

time on oxygen

Time frame: neonatal phase

length of hospital stay until discharge home

Time frame: neonatal phase

confirmed necrotizing enterocolitis

Time frame: neonatal phase

apnea requiring treatment

Time frame: neonatal phase

culture-proven infections

Time frame: neonatal phase

use of post-natal steroids

Time frame: neonatal phase

mean levels of hemoglobin

Time frame: neonatal phase

number of transfusions

Time frame: neonatal phase

number of donor exposures

Time frame: neonatal phase

serum ferritin levels

Time frame: neonatal phase

milder forms of cerebral palsy

Time frame: follow-up phase 18 months corrected age

milder neurologic disorder

Time frame: follow-up phase 18 months corrected age

personal and social functional capabilities

Time frame: follow-up phase 18 months corrected age

hydrocephalus requiring a shunt

Time frame: follow-up phase 18 months corrected age

seizure disorder

Time frame: follow-up phase 18 months corrected age

respiratory disease

Time frame: follow-up phase 18 months corrected age

iron nutritional status

Time frame: follow-up phase 18 months corrected age

physical growth including head size

Time frame: follow-up phase 18 months corrected age