Elsevier

The Journal of Pediatrics

Volume 149, Issue 3, September 2006, Pages 301-307.e3
The Journal of Pediatrics

Original article
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

https://doi.org/10.1016/j.jpeds.2006.05.011Get rights and content

Objective

To determine whether extremely low birth weight infants (ELBW) transfused at lower hemoglobin thresholds versus higher thresholds have different rates of survival or morbidity at discharge.

Study design

Infants weighing <1000 g birth weight were randomly assigned within 48 hours of birth to a transfusion algorithm of either low or high hemoglobin transfusion thresholds. The composite primary outcome was death before home discharge or survival with any of either severe retinopathy, bronchopulmonary dysplasia, or brain injury on cranial ultrasound. Morbidity outcomes were assessed, blinded to allocation.

Results

Four hundred fifty-one infants were randomly assigned to low (n = 223) or high (n = 228) hemoglobin thresholds. Groups were similar, with mean birth weight of 770 g and gestational age of 26 weeks. Fewer infants received one or more transfusions in the low threshold group (89% low versus 95% high, P = .037). Rates of the primary outcome were 74.0% in the low threshold group and 69.7% in the high (P = .25; risk difference, 2.7%; 95% CI –3.7% to 9.2%). There were no statistically significant differences between groups in any secondary outcome.

Conclusions

In extremely low birth weight infants, maintaining a higher hemoglobin level results in more infants receiving transfusions but confers little evidence of benefit.

Section snippets

Study Population

Newborn infants were enrolled from 10 neonatal intensive care units in Canada, the United States, and Australia (Appendix; available at www.jpeds.com). Eligible babies were required to be of birth weight <1000 g, gestational age <31 weeks, and to be <48 hours old at the time of enrollment. Infants deemed non-viable by the attending physician were excluded, as were those with cyanotic heart disease, congenital anemia, acute shock, transfusion after 6 hours of age, or known parental opposition to

Study Population

A total of 795 infants were screened for entry into the study from January 2000 to February 2003 inclusive, of whom 694 were eligible and 451 were subsequently randomly assigned (Figure 1; available at www.jpeds.com). Consent was not obtained for 136 infants, and the parents of 107 were not approached to participate because parents were not available or not accessible for consent within 48 hours of birth. Two hundred twenty-three infants were allocated to the restrictive (low threshold) group

Discussion

In this randomized, controlled trial, we allocated acutely ill, ELBW infants during their first 2 days of life to an algorithm of either a low or a high hemoglobin transfusion threshold, which was maintained until discharge. As a result, the high threshold group had a mean hemoglobin concentration about 10 g/L higher than the low threshold group during the first 4 weeks of life. This difference in hemoglobin level slowly dissipated over the neonatal hospitalization period as blood sampling

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    This study was supported by the Canadian Institutes Health Research (FR No. 41549) 2000-2004.

    Registration Number: www.clinicaltrials.gov NCT 00182390.

    1

    Drs Kirpalani and Whyte are co-principals.

    A complete list of the PINT Investigators is available at www.jpeds.com.

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