Clinical Trial: Premature Infants in Need of Transfusion (PINT)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
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 Summary:
Sponsor: McMaster University
Current Primary Outcome:
- 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 ]
Original Primary Outcome:
- Neonatal phase:
- Survival to tertiary hospital discharge without severe morbidity (one or all of bronchopulmonary dysplasia, retinopathy of prematurity Grade 3-4, periventricular leukomalacia/ventriculomegaly present on ultra-sound scans at corrected age 34 weeks)
- Follow-up phase:
- Combined mortality or neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay) at 18 months corrected age
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- Neonatal phase:
- growth in weight and head circumference
- time to extubation
- time on oxygen
- length of hospital stay until discharge home
- incidences of necrotizing enterocolitis
- apnea requiring treatment
- number of infections
- use of post-natal steroids
- intraventricular hemorrhage Grade 4 or with hydrocephalus
- mean levels of hemoglobin
- number of transfusions
- number of donor exposures
- Follow-up phase:
- milder forms of cerebral palsy
- milder neurologic disorder
- personal and social functional capabilities
- hydrocephalus requiring a shunt
- seizure disorder
- respiratory disease
- iron nutritional status
- physical growth including head size
Information By: McMaster University
Dates:
Date Received: September 13, 2005
Date Started: February 2001
Date Completion:
Last Updated: September 22, 2015
Last Verified: September 2015