A Phase 3 interventional study of Red blood cell transfusion in Anemia of Prematurity, sponsored by McMaster University. Completed at 10 sites in 3 countries. Open to participants aged Up to 48 Hours. Per ClinicalTrials.gov, last updated 2015-09-24.
Sponsored by McMaster University · Phase 3, Interventional, and Treatment
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 424 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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