Anemia of Prematurity
Conditions
Keywords
ELBW premature infants, neonatal transfusion, bronchopulmonary dysplasia, periventricular leukomalacia, ventriculomegaly, retinopathy of prematurity
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.
Interventions
PROCEDURERed blood cell transfusion
Sponsors
Canadian Institutes of Health Research (CIHR)
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) | neonatal phase |
| Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay) | follow-up phase 18 months corrected age |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| growth in weight and head circumference | 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 |
| serum ferritin levels | neonatal phase |
| time to extubation | neonatal phase |
Countries
Australia, Canada, United States
Outcome results
None listed