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