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Premature Infants in Need of Transfusion (PINT)

NCT00182390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2015-09-24

No results posted yet for this study

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

Interventions

PROCEDURE

Red blood cell transfusion

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McMaster University

    lead OTHER

Principal Investigators

  • Haresh Kirpalani, MD, MSc · McMaster University

  • Robin K Whyte, MD · Dalhousie University

  • Robin S Roberts, MTech · McMaster University

  • Elizabeth Asztalos, MD, MSc · Sunnybrook & Women's College Health Sciences Centre

  • Chad Andersen, MD · Mercy Hospital for Women

  • Morris Blajchman, PhD · McMaster University

  • Nancy Heddle, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2003-02-28
Completion
2005-11-30

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00182390 on ClinicalTrials.gov