NCT03303573

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

3.9 years

First QC Date

August 18, 2017

Last Update Submit

October 7, 2017

Conditions

Cerebral Palsy

Keywords

Erythropoeitin

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    telephone interview was conducted to collect information of adverse events from all patients.

    interview was performed at an average of 1 year after the completion of rhEPO injections

Secondary Outcomes (1)

  • 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

Study Arms (1)

recombinant human erythropoietin group

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

Drug: recombinant human erythropoietin

Interventions

recombinant human erythropoietinDRUG

Subcutaneous rhEPO injection

Also known as: rhEPO
recombinant human erythropoietin group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children diagnosed with cerebral palsy who had received recombinant human erythropoietin more than once.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2017

First Posted

October 6, 2017

Study Start

January 1, 2013

Primary Completion

November 30, 2016

Study Completion

August 1, 2017

Last Updated

October 10, 2017

Record last verified: 2017-10