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

NCT ID: NCT03303573

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cerebral Palsy

Keywords

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Erythropoeitin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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recombinant human erythropoietin group

cerebral palsy patients who had received erythropoietin from January 2013 to November 2016

recombinant human erythropoietin

Intervention Type DRUG

Subcutaneous rhEPO injection

Interventions

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recombinant human erythropoietin

Subcutaneous rhEPO injection

Intervention Type DRUG

Other Intervention Names

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rhEPO

Eligibility Criteria

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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.
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Bundang CHA Hospital

OTHER

Sponsor Role lead

Responsible Party

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MinYoung Kim, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Multiple EPO

Identifier Type: -

Identifier Source: org_study_id