Effects of Liberal vs Restrictive Transfusion Thresholds on Survival and Neurocognitive Outcomes in Extremely Low-Birth-Weight Infants: The ETTNO Randomized Clinical Trial.

Autor:	Franz AR; Center for Pediatric Clinical Studies, University Children's Hospital Tübingen, Tübingen, Germany.; Neonatology, University Children's Hospital Tübingen, Tübingen, Germany., Engel C; Center for Pediatric Clinical Studies, University Children's Hospital Tübingen, Tübingen, Germany., Bassler D; University Hospital Zurich, Department of Neonatology, University of Zurich, Zurich, Switzerland., Rüdiger M; Clinic for Pediatrics, Department for Neonatology and Pediatric Intensive Care Medicine, Medical Faculty, TU Dresden, Dresden, Germany., Thome UH; Children's Hospital, Division of Neonatology, Department of Women and Children's Health, University of Leipzig, Leipzig, Germany., Maier RF; Children's Hospital, University Hospital, Philipps University Marburg, Marburg, Germany., Krägeloh-Mann I; Department of Paediatric Neurology and Developmental Medicine, University Children's Hospital Tübingen, Tübingen, Germany., Kron M; Institute for Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany., Essers J; University Hospital Ulm, Ulm, Germany., Bührer C; Charité Universitätsmedizin Berlin, Berlin, Germany., Rellensmann G; Pediatrics, University Hospital Münster, Münster, Germany., Rossi R; Vivantes Klinikum Neukölln, Berlin, Germany., Bittrich HJ; Helios Klinikum Erfurt, Erfurt, Germany., Roll C; Vestische Kinder-und Jugendklinik Datteln, Universität Witten/Herdecke, Datteln, Germany., Höhn T; Neonatology and Pediatric Intensive Care, University Hospital Düsseldorf, Düsseldorf, Germany., Ehrhardt H; Department of General Pediatrics and Neonatology, Justus-Liebig-University Giessen, Giessen, Germany., Avenarius S; Pediatrics, University Hospital Magdeburg, Magdeburg, Germany., Körner HT; Neonatology, Klinikum Links der Weser, Bremen, Germany., Stein A; Department of Paediatrics I, University Duisburg-Essen, Essen, Germany., Buxmann H; University Hospital Frankfurt, Frankfurt, Germany., Vochem M; Olgahospital, Klinikum Stuttgart, Stuttgart, Germany., Poets CF; Neonatology, University Children's Hospital Tübingen, Tübingen, Germany.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2020 Aug 11; Vol. 324 (6), pp. 560-570.
DOI:	10.1001/jama.2020.10690
Abstrakt:	Importance: Red blood cell transfusions are commonly administered to infants weighing less than 1000 g at birth. Evidence-based transfusion thresholds have not been established. Previous studies have suggested higher rates of cognitive impairment with restrictive transfusion thresholds. Objective: To compare the effect of liberal vs restrictive red blood cell transfusion strategies on death or disability. Design, Setting, and Participants: Randomized clinical trial conducted in 36 level III/IV neonatal intensive care units in Europe among 1013 infants with birth weights of 400 g to 999 g at less than 72 hours after birth; enrollment took place between July 14, 2011, and November 14, 2014, and follow-up was completed by January 15, 2018. Interventions: Infants were randomly assigned to liberal (n = 492) or restrictive (n = 521) red blood cell transfusion thresholds based on infants' postnatal age and current health state. Main Outcome and Measures: The primary outcome, measured at 24 months of corrected age, was death or disability, defined as any of cognitive deficit, cerebral palsy, or severe visual or hearing impairment. Secondary outcome measures included individual components of the primary outcome, complications of prematurity, and growth. Results: Among 1013 patients randomized (median gestational age at birth, 26.3 [interquartile range {IQR}, 24.9-27.6] weeks; 509 [50.2%] females), 928 (91.6%) completed the trial. Among infants in the liberal vs restrictive transfusion thresholds groups, respectively, incidence of any transfusion was 400/492 (81.3%) vs 315/521 (60.5%); median volume transfused was 40 mL (IQR, 16-73 mL) vs 19 mL (IQR, 0-46 mL); and weekly mean hematocrit was 3 percentage points higher with liberal thresholds. Among infants in the liberal vs restrictive thresholds groups, the primary outcome occurred in 200/450 (44.4%) vs 205/478 (42.9%), respectively, for a difference of 1.6% (95% CI, -4.8% to 7.9%; P = .72). Death by 24 months occurred in 38/460 (8.3%) vs 44/491 (9.0%), for a difference of -0.7% (95% CI, -4.3% to 2.9%; P = .70), cognitive deficit was observed in 154/410 (37.6%) vs 148/430 (34.4%), for a difference of 3.2% (95% CI, -3.3% to 9.6%; P = .47), and cerebral palsy occurred in 18/419 (4.3%) vs 25/443 (5.6%), for a difference of -1.3% (95% CI, -4.2% to 1.5%; P = .37), in the liberal vs the restrictive thresholds groups, respectively. In the liberal vs restrictive thresholds groups, necrotizing enterocolitis requiring surgical intervention occurred in 20/492 (4.1%) vs 28/518 (5.4%); bronchopulmonary dysplasia occurred in 130/458 (28.4%) vs 126/485 (26.0%); and treatment for retinopathy of prematurity was required in 41/472 (8.7%) vs 38/492 (7.7%). Growth at follow-up was also not significantly different between groups. Conclusions and Relevance: Among infants with birth weights of less than 1000 g, a strategy of liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age. Trial Registration: ClinicalTrials.gov Identifier: NCT01393496.
Databáze:	MEDLINE
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