Original articleThe 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
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.
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Drs Kirpalani and Whyte are co-principals.
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A complete list of the PINT Investigators is available at www.jpeds.com.