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Neurodevelopment Outcomes Following Severe Hand Foot and Mouth Disease in Vietnam

NCT02066714 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 243

Last updated 2016-10-04

No results posted yet for this study

Summary

Hand Foot and Mouth Disease (HFMD) is a common infectious disease in childhood. Several enteroviruses are associated with the disease. However, since 1997, large outbreaks of HFMD in Taiwan, Malaysia and Vietnam have seen unusual neurological complications such as brainstem encephalitis with rare fatal outcomes. The pathogen associated with this severe disease is Enterovirus 71.

In 2011, Vietnam had a large outbreak of Hand Foot and mouth disease resulting in 110,000 cases and 164 deaths. HFMD affects children during their early years of child development, but there is limited information on what the potential long-term consequences are. Small studies have suggested language and cognitive difficulties in more severe disease but this has not been evaluated in a large cohort.

Internationally recognized and standardized assessment tools are not available for early childhood in Vietnam. This project will translate and adapt the Bayley Scales of Toddler and Infant Development 3rd edition (Bayley III) and Movement ABC, 2nd edition (MABC) into Vietnamese as outcome measures.

This study will evaluate whether there are neurodevelopment difficulties following severe HFMD. The study design is a prospective observational cohort study. Hospitalised children with a clinical diagnosis of HFMD will be eligible to enroll. Written parental consent will be required. Participants enrolled will be assessed 3 times over 18 months from discharge from hospital into the study. Since there is no standardization of Bayley III or MABC for Vietnam, a healthy cohort, age and sex matched to the least severe HFMD participants will be recruited. This healthy cohort will follow the same assessment program over 18 months. A total of 350 HFMD participants and 150 healthy children (matched to the least severe HFMD participants) will be recruited.

Conditions

  • Hand Foot and Mouth Disease

Sponsors & Collaborators

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Children's Hospital Number 1, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Preventative Medical Centre, District 8, Ho Chi Minh City, Vietnam

    collaborator UNKNOWN

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Saraswathy Sabanathan, MRCPCH · Oxford University Clinical Reserach Unt, HCMC, Vietnam

Eligibility

Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-12-31
Completion
2016-08-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066714 on ClinicalTrials.gov