Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants
- PMID: 33382931
- PMCID: PMC8487591
- DOI: 10.1056/NEJMoa2020248
Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants
Abstract
Background: Limited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia.
Methods: We performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds until 36 weeks of postmenstrual age or discharge, whichever occurred first. The primary outcome was a composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss) at 22 to 26 months of age, corrected for prematurity.
Results: A total of 1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization. There was a between-group difference of 1.9 g per deciliter (19 g per liter) in the pretransfusion mean hemoglobin levels throughout the treatment period. Primary outcome data were available for 1692 infants (92.8%). Of 845 infants in the higher-threshold group, 423 (50.1%) died or survived with neurodevelopmental impairment, as compared with 422 of 847 infants (49.8%) in the lower-threshold group (relative risk adjusted for birth-weight stratum and center, 1.00; 95% confidence interval [CI], 0.92 to 1.10; P = 0.93). At 2 years, the higher- and lower-threshold groups had similar incidences of death (16.2% and 15.0%, respectively) and neurodevelopmental impairment (39.6% and 40.3%, respectively). At discharge from the hospital, the incidences of survival without severe complications were 28.5% and 30.9%, respectively. Serious adverse events occurred in 22.7% and 21.7%, respectively.
Conclusions: In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity. (Funded by the National Heart, Lung, and Blood Institute and others; TOP ClinicalTrials.gov number, NCT01702805.).
Copyright © 2020 Massachusetts Medical Society.
Conflict of interest statement
Dr. Carlo reports receiving fees for serving as director from Mednax. No other potential conflict of interest relevant to this article was reported.
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Comment in
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Red blood cell transfusion thresholds in extremely low birth weight infants II.Acta Paediatr. 2021 Sep;110(9):2658-2659. doi: 10.1111/apa.15953. Epub 2021 Jun 13. Acta Paediatr. 2021. PMID: 34121226 No abstract available.
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Is a higher hemoglobin transfusion threshold better for extremely low birthweight infants?J Perinatol. 2022 Jun;42(6):839-841. doi: 10.1038/s41372-022-01358-w. Epub 2022 Mar 5. J Perinatol. 2022. PMID: 35249101 No abstract available.
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References
-
- Kirpalani H, Whyte RK, Andersen C, et al.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; 149: 301–7. - PubMed
-
- Whyte R, Kirpalani H. Low versus high haemoglobin concentration threshold for blood transfusion for preventing morbidity and mortality in very low birth weight infants. Cochrane Database Syst Rev 2011; 11: CD000512. - PubMed
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