Effect of Erythropoietin on Preterm Brain Injury

Premature Birth Clinical Trial

— EPO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036073
• Other study ID #: CZZ-EPO
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2013
• Last updated: January 13, 2014
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Zhengzhou Children's Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants, which is related with the development of cerebral palsy. The current therapy is only supportive to maintain the live sign stable. There is no effective therapeutic strategy for preterm brain injury. Erythropoietin (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries in animal models of brain injury, and clinical trials of neonatal hypoxic ischemic brain injury. Furthermore, recombinant human Epo (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity during the past decade. It has been considered to be safe and well tolerated in preterm infants. However, there is no conclusion yet if the EPO has the effect to prevent preterm brain injury. The purpose of the study was whether the rhEpo (500 U/kg) given to very preterm infants (gestation age < 32 weeks) within 24h after birth and subsequently each other day for2 week possesses neuroprotective properties. Very preterm infants with gestational age of < 32 weeks and admit to our NICU are eligible for enrollment. After informed consent is obtained, infants will be randomly assigned to either EPO group or vehicle group. The primary short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL)) and ROP. The long term outcomes are whether rhEpo in very preterm infants finally improves neurodevelopmental outcome at 18 months corrected age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: December 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 72 Days

Eligibility

Inclusion Criteria:

• Preterm infants admitted to the NICU with gestational age <32 weeks

• birth weight <1500g and less than 72hours of age

Exclusion Criteria:

• 1. Infants with genetic metabolic diseases

2. Congenital abnormalities

3. Pneumothorax

4. Grade III-IV intracranial hemorrhage

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth

Intervention

Drug:
• recombinant human erythropoietin
rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.

Locations

Country	Name	City	State
China	Zhengzhou Children's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Zhengzhou Children's Hospital, China	Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MDI<70		At corrected age of 18 months	Yes
Secondary	Incidence of ROP		At the corrected age 42 weeks	Yes