NCT00182390

Premature Infants in Need of Transfusion (PINT)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (planned)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 48 Hours
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anemia of Prematurity

Interventions

Type	Name	Description
PROCEDURE	Red blood cell transfusion

Timeline

• Start date: 2001-02-01
• Primary completion: 2003-02-01
• Completion: 2005-11-01
• First posted: 2005-09-16
• Last updated: 2015-09-24

Locations

10 sites across 3 countries: United States, Australia, Canada