Safety and Efficacy of Multiple EPO Injections in Children With Cerebral Palsy

Completed

• Conditions: Cerebral Palsy
• Interventions: Drug: recombinant human erythropoietin

• Registration Number: NCT03303573
• Lead Sponsor: Bundang CHA Hospital

Brief Summary

This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy

Detailed Description

Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. The safety and feasibility of EPO in children were proven in previous clinical trials. In addition, the efficacy of EPO is actively being investigated and some reports have shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2016-11-30
• Study Completion: 2017-08
• Study First Submitted: 2017-08-18
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-06
• Last Update Submitted: 2017-10-07
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 164

Inclusion Criteria

• confirmed clinical diagnosis of cerebral palsy based on neuromotor findings,
• less than 18 years of age,
• received recombinant human erythropoietin (rhEPO) more than once.

Exclusion Criteria

• not responding to phone interview or
• no functional assessments available.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
recombinant human erythropoietin group	recombinant human erythropoietin	cerebral palsy patients who had received erythropoietin from January 2013 to November 2016

Primary Outcome Measures

Name	Time	Method
Adverse events	interview was performed at an average of 1 year after the completion of rhEPO injections	telephone interview was conducted to collect information of adverse events from all patients.

Secondary Outcome Measures

Name	Time	Method
Change of Gross Motor Function Measure	The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared	The change of GMFM score before and after rhEPO injections