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Completed

NCT Number: NCT03303573

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant human erythropoietin

Drug

Subcutaneous rhEPO injection

Other names: rhEPO

Primary outcomes

  1. Adverse events

    Time frame: 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 outcomes

  1. Change of Gross Motor Function Measure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bundang CHA Hospital

Other

Registry information

Official study title

Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 6, 2017
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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