Effect of Erythropoietin on Preterm Brain Injury
EPO
1 other identifier
interventional
490
1 country
1
Brief Summary
EPO has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological indicators and explore the neuroprotective mechanism of EPO.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedJanuary 14, 2014
January 1, 2014
3.4 years
December 10, 2013
January 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of MDI<70
At corrected age of 18 months
Secondary Outcomes (1)
Incidence of ROP
At the corrected age 42 weeks
Study Arms (1)
EPO
EXPERIMENTALIn EPO group, the EPO was given by 500IU/kg every other day intravenously for 2 weeks. Recombinant human erythropoietin was configured by the hospital pharmacy intravenous Center Configuration, melted configured with saline to 1ml/kg solution. For severe patients, they were started to treat with EPO when their vital signs, blood pressure were stable.
Interventions
rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.
Eligibility Criteria
You may qualify if:
- Preterm infants admitted to the NICU with gestational age \<32 weeks
- birth weight \<1500g and less than 72hours of age
You may not qualify if:
- \. Infants with genetic metabolic diseases
- \. Congenital abnormalities
- \. Pneumothorax
- \. Grade III-IV intracranial hemorrhage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhengzhou Children's Hospital, Chinalead
- Zhengzhou Universitycollaborator
Study Sites (1)
Zhengzhou Children's Hospital
Zhengzhou, Henan, 450053, China
Related Publications (1)
Sun H, Song J, Kang W, Wang Y, Sun X, Zhou C, Xiong H, Xu F, Li M, Zhang X, Yu Z, Peng X, Li B, Xu Y, Xing S, Wang X, Zhu C. Effect of early prophylactic low-dose recombinant human erythropoietin on retinopathy of prematurity in very preterm infants. J Transl Med. 2020 Oct 19;18(1):397. doi: 10.1186/s12967-020-02562-y.
PMID: 33076939DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 10, 2013
First Posted
January 14, 2014
Study Start
January 1, 2009
Primary Completion
June 1, 2012
Study Completion
December 1, 2013
Last Updated
January 14, 2014
Record last verified: 2014-01