Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants.
(Journal Article;Multicenter Study)
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.).
Kirpalani, H; Bell, EF; Hintz, SR; Tan, S; Schmidt, B; Chaudhary, AS; Johnson, KJ; Crawford, MM; Newman, JE; Vohr, BR; Carlo, WA; D'Angio, CT; Kennedy, KA; Ohls, RK; Poindexter, BB; Schibler, K; Whyte, RK; Widness, JA; Zupancic, JAF; Wyckoff, MH; Truog, WE; Walsh, MC; Chock, VY; Laptook, AR; Sokol, GM; Yoder, BA; Patel, RM; Cotten, CM; Carmen, MF; Devaskar, U; Chawla, S; Seabrook, R; Higgins, RD; Das, A; Eunice Kennedy Shriver NICHD Neonatal Research Network,
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