NCT00172393

Brief Summary

Our study involved 142 children with EV71 CNS infections that included 61 (43%) with viral meningitis, 53 (37%) with severe CNS involvement including encephalitis, polio-like syndrome and encephalomyelitis, and 28 (20%) with cardiopulmonary failure after CNS involvement. These children were subjected to physical and neurological examinations 2.85 (range 1.0-7.39) years after disease onset. Those below the age of 6 years took the Denver developmental screening test, while those 4 years and over took the intelligence quotient (IQ) test.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

October 4, 2006

Status Verified

June 1, 2005

First QC Date

September 12, 2005

Last Update Submit

October 3, 2006

Conditions

Central Nervous System Infection

Keywords

EV71,CNS,Outcome,Neurological,Psychiatric

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Virologically-confirmed EV71 cases with CNS involvement

You may not qualify if:

  • No evidence of EV71 infection
  • No evidence of CNS involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hsopital

Taipei, Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

  • Gau SS, Chang LY, Huang LM, Fan TY, Wu YY, Lin TY. Attention-deficit/hyperactivity-related symptoms among children with enterovirus 71 infection of the central nervous system. Pediatrics. 2008 Aug;122(2):e452-8. doi: 10.1542/peds.2007-3799. Epub 2008 Jul 7.

    PMID: 18606624DERIVED

  • Chang LY, Huang LM, Gau SS, Wu YY, Hsia SH, Fan TY, Lin KL, Huang YC, Lu CY, Lin TY. Neurodevelopment and cognition in children after enterovirus 71 infection. N Engl J Med. 2007 Mar 22;356(12):1226-34. doi: 10.1056/NEJMoa065954.

    PMID: 17377160DERIVED

MeSH Terms

Conditions

Central Nervous System InfectionsNeurologic Manifestations

Condition Hierarchy (Ancestors)

InfectionsCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luan-Yin Chang, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luan-Yin Chang, MD

CONTACT

886-2-23123456ly7077@tpts6.seed.net.tw

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 2003

Study Completion

May 1, 2005

Last Updated

October 4, 2006

Record last verified: 2005-06

Locations

TW(1)