Premature Infants in Need of Transfusion (PINT)

September 22, 2015 updated by: McMaster University

A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight

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.

Study Overview

Status

Completed

Conditions

Anemia of Prematurity

Intervention / Treatment

Procedure: Red blood cell transfusion

Study Type

Interventional

Enrollment

424

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Victoria
  - Melbourne, Victoria, Australia, 3084
    - Mercy Hospital for Women
  - Melbourne, Victoria, Australia, 3053
    - Royal Women's Hospital
Canada
- Alberta
  - Edmonton, Alberta, Canada, T5H 3T9
    - Royal Alexandra Hospital
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3P 1R8
    - IWK Health Centre
- Ontario
  - Hamilton, Ontario, Canada, L8S 4J9
    - McMaster University
  - Kingston, Ontario, Canada, K7L 2V7
    - Kingston General Hospital
  - Toronto, Ontario, Canada, M5S 1B2
    - Sunnybrook & Women's College Health Science Centre
- Quebec
  - Montreal, Quebec, Canada, H3A 1A1
    - Royal Victoria Hospital
United States
- New York
  - Albany, New York, United States, 12208
    - Albany Medical Center
  - Brooklyn, New York, United States, 11201
    - Brooklyn Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) Time Frame: neonatal phase	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	follow-up phase 18 months corrected age

Secondary Outcome Measures

Outcome Measure	Time Frame
growth in weight and head circumference Time Frame: neonatal phase	neonatal phase
time to extubation Time Frame: neonatal phase	neonatal phase
time on oxygen Time Frame: neonatal phase	neonatal phase
length of hospital stay until discharge home Time Frame: neonatal phase	neonatal phase
confirmed necrotizing enterocolitis Time Frame: neonatal phase	neonatal phase
apnea requiring treatment Time Frame: neonatal phase	neonatal phase
culture-proven infections Time Frame: neonatal phase	neonatal phase
use of post-natal steroids Time Frame: neonatal phase	neonatal phase
mean levels of hemoglobin Time Frame: neonatal phase	neonatal phase
number of transfusions Time Frame: neonatal phase	neonatal phase
number of donor exposures Time Frame: neonatal phase	neonatal phase
serum ferritin levels Time Frame: neonatal phase	neonatal phase
milder forms of cerebral palsy Time Frame: follow-up phase 18 months corrected age	follow-up phase 18 months corrected age
milder neurologic disorder Time Frame: follow-up phase 18 months corrected age	follow-up phase 18 months corrected age
personal and social functional capabilities Time Frame: follow-up phase 18 months corrected age	follow-up phase 18 months corrected age
hydrocephalus requiring a shunt Time Frame: follow-up phase 18 months corrected age	follow-up phase 18 months corrected age
seizure disorder Time Frame: follow-up phase 18 months corrected age	follow-up phase 18 months corrected age
respiratory disease Time Frame: follow-up phase 18 months corrected age	follow-up phase 18 months corrected age
iron nutritional status Time Frame: follow-up phase 18 months corrected age	follow-up phase 18 months corrected age
physical growth including head size Time Frame: follow-up phase 18 months corrected age	follow-up phase 18 months corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria