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Premature Infants in Need of Transfusion (PINT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00182390
First Posted: September 16, 2005
Last Update Posted: September 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
  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
Intervention Model: Parallel Assignment
Masking: None (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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 424
Study Start Date: February 2001
Study Completion Date: November 2005
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Royal Women's Hospital
Melbourne, Victoria, Australia, 3053
Mercy Hospital for Women
Melbourne, Victoria, Australia, 3084
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
McMaster University
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
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: September 24, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications