Clinical Trial: Long Term Outcomes of EV71 CNS Infection

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Long Term Outcomes of EV71 Central Nervous System Infection

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.

Detailed Summary:

For the purposes of our study we identified all the EV71 pediatric patients at Chang Gung Children’s Hospital (CGCH) and at the NTUH between 1998 and 2003. These patients were clinically confirmed to have hand, foot, and mouth disease (HFMD) of herpangina or febrile illness, and a positive laboratory-confirmed EV71 infection. The EV 71 infection was confirmed on the basis of a positive viral isolation of EV71 and/or a positive EV71 IgM and/or a four-fold rise in EV71 neutralizing antibody serotiters between the acute and the convalescent sera.

This study involved 621 EV71 patients in total, 534 of them at the CGCH and 87 of them at the NTUH. Of these, 232 cases (37.4%) had CNS involvement. The clinical severity of the EV71 CNS involvement was classified in terms of the increasing severity of the infection: Group 1: cases with mild CNS involvement i.e. aseptic meningitis; Group 2: cases with severe CNS involvement including encephalitis, polio-like syndrome or encephalomyelitis; and Group 3: cases with cardiopulmonary failure after central nervous system involvement. Patients placed in Group 1, were those experiencing headaches, irritability and CSF pleocytosis (>5x106 leukocytes/L) but no altered level of consciousness or focal signs. Patients placed in Group 2, were encephalitis with an altered level of consciousness plus CSF pleocytosis, poliomyelitis-like syndrome with acute limb weakness, and decreased reflex and muscle strength, and encephalomyelitis with the occurrence of both encephalitis and poliomyelitis-like syndrome. Patients placed in Group 3 were those who had experienced cardiopulmonary failure (defined as a decreased ejection fraction of the left ventricle as assessed by echocardiography with or without pulmonary edema/hemorrhage, necessitating inotropic agent and ventilator support). Patients who experienced cardiopulmonary failure after CNS invol
Sponsor: National Taiwan University Hospital

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Taiwan University Hospital

Dates:
Date Received: September 12, 2005
Date Started: January 2003
Date Completion: May 2005
Last Updated: October 3, 2006
Last Verified: June 2005