Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage

Phase 2 Completed 316 enrolled Zhengzhou University Göteborg University · collab Zhengzhou Children's Hospital, China · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). The aim of this study is to evaluate the long-term neuroprotective effect of repeated low-dose EPO (500 U/kg) in very preterm infants with IVH.

Timeline

Start: 2014-07
Primary completion: 2019-07
Completion: 2019-07

Outcome

Met primary endpoint

paper significantly fewer infants had poor outcomes (death and neurological disability) in the rhEPO group: 14.9 vs. 26.4%; PMID 33959935 ↗

paper 14.9 vs. 26.4%; odds ratio (OR) 0.398; 95% confidence interval (CI) 0.199-0.796; p = 0.009. PMID 33959935 ↗

Publications

Song J, Wang Y, Xu F, Sun H, Zhang X, Xia L, Zhang S, Li K, Peng X, Li B, Zhang Y, Kang W, Wang X, Zhu C. Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage. CNS Drugs. 2021 Jun;35(6):681-690. doi: 10.1007/s40263-021-00817-w. Epub 2021 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	500 iu/kg	Intravenous

Indications

No indication recorded.