Trial record 3 of 54 for:    Periventricular Leukomalacia

Premature Infants in Need of Transfusion (PINT)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182390
First received: September 13, 2005
Last updated: November 29, 2006
Last verified: October 2002
  Purpose

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.


Condition Intervention Phase
Anemia of Prematurity
Procedure: Red blood cell transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 424
Study Start Date: February 2001
  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182390

Locations
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
Australia, Victoria
Mercy Hospital for Women
Melbourne, Victoria, Australia, 3084
Royal Women's Hospital
Melbourne, Victoria, Australia, 3053
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3T9
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3P 1R8
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4J9
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, Canada, M5S 1B2
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Haresh Kirpalani, MD, MSc McMaster University
Principal Investigator: Robin K Whyte, MD Dalhousie University
Study Director: Robin S Roberts, MTech McMaster University
Study Director: Elizabeth Asztalos, MD, MSc Sunnybrook & Women's College Health Sciences Centre
Study Director: Chad Andersen, MD Mercy Hospital for Women
Study Director: Morris Blajchman, PhD McMaster University
Study Director: Nancy Heddle, MSc McMaster University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00182390     History of Changes
Other Study ID Numbers: CTMG-2001-PINT, CIHR MCT-41549, CIHR MCT-58455
Study First Received: September 13, 2005
Last Updated: November 29, 2006
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
ELBW premature infants
neonatal transfusion
bronchopulmonary dysplasia
periventricular leukomalacia
ventriculomegaly
retinopathy of prematurity

Additional relevant MeSH terms:
Anemia
Anemia, Neonatal
Infant, Premature, Diseases
Hematologic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 21, 2014