Safety of High Dose Erythropoietin Used with Therapeutic Hypothermia as Treatment for Newborn Hypoxic-Ischemic Encephalopathy: Secondary Analysis of the HEAL Randomized Controlled Trial - 05/07/23
, Bryan A. Comstock, MS 2, Marie-Coralie Cornet, MD 3, Fernando F. Gonzalez, MD 3, Dennis E. Mayock, MD 1, Hannah C. Glass, MDCM, MAS 3, 4, Michael D. Schreiber, MD 5, Patrick J. Heagerty, PhD 2, Yvonne W. Wu, MD, MPH 3, 4Abstract |
Objective |
To assess whether high dose erythropoietin (Epo) treatment of cooled infants with neonatal hypoxic ischemic encephalopathy results in a higher risk of prespecified serious adverse events (SAEs).
Study design |
Five hundred infants born at ≥36 weeks of gestation with moderate or severe hypoxic ischemic encephalopathy undergoing therapeutic hypothermia were randomized to Epo or placebo on days 1, 2, 3, 4, and 7. Pretreatment and posttreatment SAEs were compared with adjusted generalized linear models, with posttreatment models adjusted for the presence of a pretreatment SAE. Clinical risk factors and potential mechanisms for SAEs were also examined.
Results |
The rate of experiencing at least one posttreatment SAE did not significantly differ between groups (adjusted relative risk [aRR], 95% CI: 1.17, 0.92-1.49); however, posttreatment thrombosis was identified more often in the Epo group (n = 6, 2.3%) than the placebo group (n = 1, 0.4%; aRR, 95% CI: 5.09, 1.32-19.64). The rate of posttreatment intracranial hemorrhage identified at the treatment sites by either ultrasound or magnetic resonance imaging was slightly elevated in the Epo group (n = 61, 24%) but not significantly different from the placebo group (n = 46, 19%; aRR, 95% CI: 1.21, 0.85, 1.72).
Conclusions |
A small increased risk of major thrombotic events was identified in the Epo treatment group.
Trial registration |
NCT02811263.
Le texte complet de cet article est disponible en PDF.Abbreviations : DIC, Epo, HEAL, HIE, ICH, MRI, RR, SAE, TH, aRR
Plan
| This submission is on behalf of the HEAL Consortium (see ; available at www.jpeds.com). |
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| Funded by NIH NINDS 1U01NS092764 and U01NS092553. The study sponsor had no involvement in 1) study design; 2) the collection, analysis, and interpretation of data; 3) the writing of the report; or 4) the decision to submit the paper for publication. |
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| The authors declare no conflicts of interest. |
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Article 113400- juillet 2023 Retour au numéro
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