A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 424
- Locations
- 20
- Primary Endpoint
- Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 48 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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(neonatal phase)
- time to extubation(neonatal phase)
- time on oxygen(neonatal phase)
- length of hospital stay until discharge home(neonatal phase)
- confirmed necrotizing enterocolitis(neonatal phase)
- apnea requiring treatment(neonatal phase)
- culture-proven infections(neonatal phase)
- use of post-natal steroids(neonatal phase)
- mean levels of hemoglobin(neonatal phase)
- number of transfusions(neonatal phase)
- number of donor exposures(neonatal phase)
- serum ferritin levels(neonatal phase)
- milder forms of cerebral palsy(follow-up phase 18 months corrected age)
- milder neurologic disorder(follow-up phase 18 months corrected age)
- personal and social functional capabilities(follow-up phase 18 months corrected age)
- hydrocephalus requiring a shunt(follow-up phase 18 months corrected age)
- seizure disorder(follow-up phase 18 months corrected age)
- respiratory disease(follow-up phase 18 months corrected age)
- iron nutritional status(follow-up phase 18 months corrected age)
- physical growth including head size(follow-up phase 18 months corrected age)