Clinical trial NCT00182390: Premature Infants in Need of Transfusion (PINT)
Official title: A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia of Prematurity
Keywords: ELBW premature infants
neonatal transfusion
bronchopulmonary dysplasia
periventricular leukomalacia
ventriculomegaly
retinopathy of prematurity
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-16
Enrollment: 424
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)
timeFrame: neonatal phase
measure: Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)
timeFrame: follow-up phase 18 months corrected age
Secondary outcomes:
measure: growth in weight and head circumference
timeFrame: neonatal phase
measure: time to extubation
timeFrame: neonatal phase
measure: time on oxygen
timeFrame: neonatal phase
measure: length of hospital stay until discharge home
timeFrame: neonatal phase
measure: confirmed necrotizing enterocolitis
timeFrame: neonatal phase
measure: apnea requiring treatment
timeFrame: neonatal phase
measure: culture-proven infections
timeFrame: neonatal phase
measure: use of post-natal steroids
timeFrame: neonatal phase
measure: mean levels of hemoglobin
timeFrame: neonatal phase
measure: number of transfusions
timeFrame: neonatal phase
measure: number of donor exposures
timeFrame: neonatal phase
measure: serum ferritin levels
timeFrame: neonatal phase
measure: milder forms of cerebral palsy
timeFrame: follow-up phase 18 months corrected age
measure: milder neurologic disorder
timeFrame: follow-up phase 18 months corrected age
measure: personal and social functional capabilities
timeFrame: follow-up phase 18 months corrected age
measure: hydrocephalus requiring a shunt
timeFrame: follow-up phase 18 months corrected age
measure: seizure disorder
timeFrame: follow-up phase 18 months corrected age
measure: respiratory disease
timeFrame: follow-up phase 18 months corrected age
measure: iron nutritional status
timeFrame: follow-up phase 18 months corrected age
measure: physical growth including head size
timeFrame: follow-up phase 18 months corrected age
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Hospital Center
state: New York
city: Melbourne
country: Australia
facility: Royal Women's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Mercy Hospital for Women
state: Victoria
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Science Centre
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McMaster University
name: Haresh Kirpalani, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Robin K Whyte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Robin S Roberts, MTech
role: STUDY_DIRECTOR
affiliation: Sunnybrook & Women's College Health Sciences Centre
name: Elizabeth Asztalos, MD, MSc
role: STUDY_DIRECTOR
affiliation: Mercy Hospital for Women
name: Chad Andersen, MD
role: STUDY_DIRECTOR
affiliation: McMaster University
name: Morris Blajchman, PhD
role: STUDY_DIRECTOR
affiliation: McMaster University
name: Nancy Heddle, MSc
role: STUDY_DIRECTOR
References:
citation: Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr. 2006 Sep;149(3):301-307. doi: 10.1016/j.jpeds.2006.05.011.
citation: Whyte RK, Kirpalani H, Asztalos EV, Andersen C, Blajchman M, Heddle N, LaCorte M, Robertson CM, Clarke MC, Vincer MJ, Doyle LW, Roberts RS; PINTOS Study Group. Neurodevelopmental outcome of extremely low birth weight infants randomly assigned to restrictive or liberal hemoglobin thresholds for blood transfusion. Pediatrics. 2009 Jan;123(1):207-13. doi: 10.1542/peds.2008-0338.