drugset / Trial / NCT02550054
Erythropoietin in Premature Infants to Prevent Encephalopathy
Phase 2
Terminated
58 enrolled
Children's Hospital of Fudan University
Guangzhou Women and Children's Medical Center · collabMaternal and Child Health Hospital of Guangxi Zhuang Autonomous Region · collabMaternal and Child Health Hospital of Hubei Province · collabSecond Affiliated Hospital of Wenzhou Medical University · collabThe Maternal & Children Health Hospital of Dehong, Yunnan of China · collabXiamen Children's Hospital, Fujian of China · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months corrected age. This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 312 patients.
Timeline
- Start
- 2015-09-08
- Primary completion
- 2016-12-30
- Completion
- 2016-12-30
Outcome
Outcome not reported
Stopped: “The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.”
Publications
- Background Leuchter RH, Gui L, Poncet A, Hagmann C, Lodygensky GA, Martin E, Koller B, Darque A, Bucher HU, Huppi PS. Association between early administration of high-dose erythropoietin in preterm infants and brain MRI abnormality at term-equivalent age. JAMA. 2014 Aug 27;312(8):817-24. doi: 10.1001/jama.2014.9645.
- Background Dame C, Langer J, Koller BM, Fauchere JC, Bucher HU. Urinary erythropoietin concentrations after early short-term infusion of high-dose recombinant epo for neuroprotection in preterm neonates. Neonatology. 2012;102(3):172-7. doi: 10.1159/000339283. Epub 2012 Jul 4.
- Background Kuki I, Kawawaki H, Horino A, Inoue T, Nukui M, Okazaki S, Tomiwa K, Amo K, Togawa M, Shiomi M. [A clinical study on high-dose erythropoietin therapy for acute encephalopathy or encephalitis]. No To Hattatsu. 2015 Jan;47(1):32-6. Japanese.
- Background Traudt CM, McPherson RJ, Bauer LA, Richards TL, Burbacher TM, McAdams RM, Juul SE. Concurrent erythropoietin and hypothermia treatment improve outcomes in a term nonhuman primate model of perinatal asphyxia. Dev Neurosci. 2013;35(6):491-503. doi: 10.1159/000355460. Epub 2013 Nov 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epo | Unknown | 400 iu/kg | Intravenous |