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Trial of Erythropoietin for Hypoxic-Ischemic Encephalopathy in Newborns.
Wu, Yvonne W; Comstock, Bryan A; Gonzalez, Fernando F; Mayock, Dennis E; Goodman, Amy M; Maitre, Nathalie L; Chang, Taeun; Van Meurs, Krisa P; Lampland, Andrea L; Bendel-Stenzel, Ellen; Mathur, Amit M; Wu, Tai-Wei; Riley, David; Mietzsch, Ulrike; Chalak, Lina; Flibotte, John; Weitkamp, Joern-Hendrik; Ahmad, Kaashif A; Yanowitz, Toby D; Baserga, Mariana; Poindexter, Brenda B; Rogers, Elizabeth E; Lowe, Jean R; Kuban, Karl C K; O'Shea, T Michael; Wisnowski, Jessica L; McKinstry, Robert C; Bluml, Stefan; Bonifacio, Sonia; Benninger, Kristen L; Rao, Rakesh; Smyser, Christopher D; Sokol, Gregory M; Merhar, Stephanie; Schreiber, Michael D; Glass, Hannah C; Heagerty, Patrick J; Juul, Sandra E.
  • Wu YW; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Comstock BA; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Gonzalez FF; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Mayock DE; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Goodman AM; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Maitre NL; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Chang T; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Van Meurs KP; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Lampland AL; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Bendel-Stenzel E; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Mathur AM; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Wu TW; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Riley D; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Mietzsch U; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Chalak L; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Flibotte J; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Weitkamp JH; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Ahmad KA; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Yanowitz TD; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Baserga M; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Poindexter BB; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Rogers EE; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Lowe JR; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Kuban KCK; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • O'Shea TM; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Wisnowski JL; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • McKinstry RC; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Bluml S; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Bonifacio S; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Benninger KL; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Rao R; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Smyser CD; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Sokol GM; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Merhar S; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Schreiber MD; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Glass HC; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Heagerty PJ; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
  • Juul SE; From the Departments of Neurology (Y.W.W., A.M.G., H.C.G.), Pediatrics (Y.W.W., F.F.G., E.E.R., H.C.G.), and Epidemiology (H.C.G.), University of California, San Francisco, San Francisco, the Department of Pediatrics, Stanford University School of Medicine, Stanford (K.P.V.M., S. Bonifacio), and the
N Engl J Med ; 387(2): 148-159, 2022 07 14.
Article in English | MEDLINE | ID: covidwho-1931553
ABSTRACT

BACKGROUND:

Neonatal hypoxic-ischemic encephalopathy is an important cause of death as well as long-term disability in survivors. Erythropoietin has been hypothesized to have neuroprotective effects in infants with hypoxic-ischemic encephalopathy, but its effects on neurodevelopmental outcomes when given in conjunction with therapeutic hypothermia are unknown.

METHODS:

In a multicenter, double-blind, randomized, placebo-controlled trial, we assigned 501 infants born at 36 weeks or more of gestation with moderate or severe hypoxic-ischemic encephalopathy to receive erythropoietin or placebo, in conjunction with standard therapeutic hypothermia. Erythropoietin (1000 U per kilogram of body weight) or saline placebo was administered intravenously within 26 hours after birth, as well as at 2, 3, 4, and 7 days of age. The primary outcome was death or neurodevelopmental impairment at 22 to 36 months of age. Neurodevelopmental impairment was defined as cerebral palsy, a Gross Motor Function Classification System level of at least 1 (on a scale of 0 [normal] to 5 [most impaired]), or a cognitive score of less than 90 (which corresponds to 0.67 SD below the mean, with higher scores indicating better performance) on the Bayley Scales of Infant and Toddler Development, third edition.

RESULTS:

Of 500 infants in the modified intention-to-treat analysis, 257 received erythropoietin and 243 received placebo. The incidence of death or neurodevelopmental impairment was 52.5% in the erythropoietin group and 49.5% in the placebo group (relative risk, 1.03; 95% confidence interval [CI], 0.86 to 1.24; P = 0.74). The mean number of serious adverse events per child was higher in the erythropoietin group than in the placebo group (0.86 vs. 0.67; relative risk, 1.26; 95% CI, 1.01 to 1.57).

CONCLUSIONS:

The administration of erythropoietin to newborns undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy did not result in a lower risk of death or neurodevelopmental impairment than placebo and was associated with a higher rate of serious adverse events. (Funded by the National Institute of Neurological Disorders and Stroke; ClinicalTrials.gov number, NCT02811263.).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Erythropoietin / Neuroprotective Agents / Hypoxia-Ischemia, Brain / Hypothermia, Induced Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Humans / Infant / Infant, Newborn Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Erythropoietin / Neuroprotective Agents / Hypoxia-Ischemia, Brain / Hypothermia, Induced Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Humans / Infant / Infant, Newborn Language: English Journal: N Engl J Med Year: 2022 Document Type: Article