Premature Infants in Need of Transfusion (PINT)
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2001 |
| End Date: | November 2005 |
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) 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.
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
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