Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants.
Kirpalani, Haresh B.M.; Bell, Edward F. M.D.; Hintz, Susan R. M.D.; Tan, Sylvia M.S.; Schmidt, Barbara M.D.; Chaudhary, Aasma S. B.S., R.R.T.; Johnson, Karen J. R.N., B.S.N.; Crawford, Margaret M. B.S., C.C.R.P.; Newman, Jamie E. Ph.D., M.P.H.; Vohr, Betty R. M.D.; Carlo, Waldemar A. M.D.; D'Angio, Carl T. M.D.; Kennedy, Kathleen A. M.D., M.P.H.; Ohls, Robin K. M.D.; Poindexter, Brenda B. M.D.; Schibler, Kurt M.D.; Whyte, Robin K. M.B., B.S.; Widness, John A. M.D.; Zupancic, John A.F. M.D., Sc.D.; Wyckoff, Myra H. M.D.; Truog, William E. M.D.; Walsh, Michele C. M.D.; Chock, Valerie Y. M.D.; Laptook, Abbot R. M.D.; Sokol, Gregory M. M.D.; Yoder, Bradley A. M.D.; Patel, Ravi M. M.D.; Cotten, C. Michael M.D., M.H.S.; Carmen, Melissa F. M.D.; Devaskar, Uday M.D.; Chawla, Sanjay M.D.; Seabrook, Ruth M.D.; Higgins, Rosemary D. M.D.; Das, Abhik Ph.D.; the Eunice Kennedy Shriver NICHD Neonatal Research Network
[Article]
New England Journal of Medicine.
383(27):2639-2651, December 31, 2020.
(Format: HTML, PDF)
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 (C) 2020 Massachusetts Medical Society. All rights reserved.