Premature Infants in Need of Transfusion (PINT)
- Conditions
- Anemia of Prematurity
- Registration Number
- NCT00182390
- Lead Sponsor
- McMaster University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 424
- birth weight <1000g
- postnatal age <48 hours
- no transfusion beyond first 6 hours of life
- estimated gestational age of 30 completed weeks or less
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 number of transfusions neonatal phase
Trial Locations
- Locations (10)
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Albany Medical Center
🇺🇸Albany, New York, United States
Royal Women's Hospital
🇦🇺Melbourne, Victoria, Australia
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
Mercy Hospital for Women
🇦🇺Melbourne, Victoria, Australia
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
McMaster University
🇨🇦Hamilton, Ontario, Canada
Sunnybrook & Women's College Health Science Centre
🇨🇦Toronto, Ontario, Canada