Effect of Erythropoietin on Preterm Brain Injury

NCT ID: NCT02036073

Last Updated: 2014-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-12-31

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.

Detailed 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.

Conditions

Premature Birth

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

EPO

In 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.

Group Type: EXPERIMENTAL

recombinant human erythropoietin

Intervention Type: DRUG

rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.

Interventions

recombinant human erythropoietin

rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.

Intervention Type: DRUG

Other Intervention Names

EPO

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 72 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhengzhou University

OTHER

Sponsor Role: collaborator

Zhengzhou Children's Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Huiqing Sun

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhengzhou Children's Hospital

Zhengzhou, Henan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33076939 (View on PubMed)

Other Identifiers

CZZ-EPO

Identifier Type: -

Identifier Source: org_study_id