Safety and Short-term Outcomes of High-Dose Erythropoietin in Preterm Infants With Intraventricular Hemorrhage: The EpoRepair Randomized Clinical Trial.

Autor:	Wellmann S; Department of Neonatology, University Children's Hospital Regensburg, Hospital St Hedwig of the Order of St John, University of Regensburg, Regensburg, Germany.; Division of Neonatology, University Children's Hospital Basel, University of Basel, Basel, Switzerland., Hagmann CF; Department of Neonatology and Pediatric Intensive Care, University Children's Hospital Zurich, Zurich, Switzerland.; Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland., von Felten S; Department of Biostatistics, Institute of Epidemiology, Biostatistics and Prevention, University of Zurich, Zurich, Switzerland., Held L; Department of Biostatistics, Institute of Epidemiology, Biostatistics and Prevention, University of Zurich, Zurich, Switzerland., Klebermass-Schrehof K; Department of Pediatrics and Adolescent Medicine, Medical University Vienna, Vienna, Austria., Truttmann AC; Clinic of Neonatology, Department of Women Mother Child, University Center Hospital and University of Lausanne, Vaud, Switzerland., Knöpfli C; Newborn Research, Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Fauchère JC; Newborn Research, Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Bührer C; Department of Neonatology, Charité-Universitätsmedizin Berlin, Berlin, Germany., Bucher HU; Newborn Research, Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Rüegger CM; Newborn Research, Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2022 Dec 01; Vol. 5 (12), pp. e2244744. Date of Electronic Publication: 2022 Dec 01.
DOI:	10.1001/jamanetworkopen.2022.44744
Abstrakt:	Importance: Intraventricular hemorrhage (IVH) is a major cause of neonatal morbidity and mortality in preterm infants without a specific medical treatment to date. Objective: To assess the safety and short-term outcomes of high-dose erythropoietin in preterm infants with IVH. Design, Setting, and Participants: Between April 1, 2014, and August 3, 2018, a randomized double-blind clinical trial enrolled 121 preterm infants (gestational age <32 weeks or birth weight <1500 g) aged 8 or less days with moderate to severe IVH identified by cerebral ultrasonography from 8 Swiss and Austrian tertiary neonatal units. Statistical analyses were performed between October 1, 2019, and September 12, 2022. Interventions: Infants received intravenous high-dose erythropoietin (2000 units/kg body weight) or placebo at 4 time points between weeks 1 and 4 of life. Main Outcomes and Measures: Secondary outcomes included (1) mortality and morbidity rates and (2) brain magnetic resonance imaging findings at term-equivalent age (TEA). The primary outcome was the composite intelligence quotient at 5 years of age (not available before 2023). Results: Sixty infants (48% male [n = 29]) were randomly assigned to receive erythropoietin, and 61 infants (61% male [n = 37]) were randomly assigned to receive placebo. The median birth weight was 832 g (IQR, 687-990 g) in the erythropoietin group and 870 g (IQR, 680-1110 g) in the placebo group. Median gestation was 26.1 weeks (IQR, 24.8-27.3 weeks) in the erythropoietin group and 27.0 weeks (24.9-28.1 weeks) in the placebo group. The 2 groups had similar baseline characteristics and morbidities. Up to TEA, 10 newborns died (16.7%) in the erythropoietin group, and 5 newborns (8.2%) died in the placebo group (adjusted odds ratio, 2.24 [95% CI, 0.74-7.66]; P = .15). Infants receiving erythropoietin had higher mean hematocrit levels. Conventional magnetic resonance imaging at TEA for 100 infants showed no significant differences in global or regional brain injury scores. Conclusions and Relevance: This preliminary report of a randomized clinical trial found no evidence that high-dose erythropoietin in preterm infants with IVH affects brain injury scores on conventional magnetic resonance imaging at TEA. Higher mortality in the erythropoietin group was not significant but should be reassessed based on future results from similar trials. Trial Registration: ClinicalTrials.gov Identifier: NCT02076373.
Databáze:	MEDLINE
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