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

Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03303573
Enrollment
164
Registered
2017-10-06
Start date
2013-01-01
Completion date
2017-08-31
Last updated
2017-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Erythropoeitin

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.

Interventions

DRUGrecombinant human erythropoietin

Subcutaneous rhEPO injection

Sponsors

Bundang CHA Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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.

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventsinterview was performed at an average of 1 year after the completion of rhEPO injectionstelephone interview was conducted to collect information of adverse events from all patients.

Secondary

MeasureTime frameDescription
Change of Gross Motor Function MeasureThe results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were comparedThe change of GMFM score before and after rhEPO injections

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026