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
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Brooklyn Hospital Center Welcome to The Brooklyn Hospital Center, dedicated to Keeping Brooklyn healthy and...
Click here to add this to my saved trials