Premature Infants in Need of Transfusion (PINT)

NCT00182390 | Completed Phase 3

• 3 other identifiers: CTMG-2001-PINTCIHR MCT-41549CIHR MCT-58455
• Study Type: interventional
• Target: 424
• Locations: 3 countries
• Sites: 10

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.

Conditions

Anemia of Prematurity

Keywords

ELBW premature infants; neonatal transfusion; bronchopulmonary dysplasia; periventricular leukomalacia; ventriculomegaly; retinopathy of prematurity

Outcome Measures

Primary Outcomes (2)

• Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)

  neonatal phase

• Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)

  follow-up phase 18 months corrected age

Secondary Outcomes (20)

• growth in weight and head circumference

  neonatal phase

• time to extubation

  neonatal phase

• time on oxygen

  neonatal phase

• length of hospital stay until discharge home

  neonatal phase

• confirmed necrotizing enterocolitis

  neonatal phase

Interventions

Red blood cell transfusion PROCEDURE

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• birth weight \<1000g
• postnatal age \<48 hours
• no transfusion beyond first 6 hours of life
• estimated gestational age of 30 completed weeks or less

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (10)

Albany Medical Center

Albany, New York, 12208, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

Royal Women's Hospital

Melbourne, Victoria, 3053, Australia

Location

Mercy Hospital for Women

Melbourne, Victoria, 3084, Australia

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3T9, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3P 1R8, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4J9, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Sunnybrook & Women's College Health Science Centre

Toronto, Ontario, M5S 1B2, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (2)

• 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.

  PMID: 16939737 RESULT

• 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.

  PMID: 19117884 RESULT

MeSH Terms

Conditions

Anemia; Bronchopulmonary Dysplasia; Leukomalacia, Periventricular; Hydrocephalus; Retinopathy of Prematurity

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Haresh Kirpalani, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

• Robin K Whyte, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2001
• Primary Completion: February 1, 2003
• Study Completion: November 1, 2005
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

AU (2); US (2); CA (6)