Neurodevelopment Outcomes Following Severe Hand Foot and Mouth Disease in Vietnam (08RS)
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|ClinicalTrials.gov Identifier: NCT02066714|
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : October 4, 2016
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.
|Condition or disease|
|Hand Foot and Mouth Disease|
|Study Type :||Observational|
|Actual Enrollment :||243 participants|
|Observational Model:||Case Control|
|Official Title:||A Prospective Cohort Study Evaluating Prognostic Indicators and Sequelae Following Severe Hand Foot and Mouth Disease|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||August 2016|
These children will be recruited from district 8, Ho Chi Minh City where most HFMD admissions to the Hospital for Tropical Diseases occur. We wil recruit healthy children from three kindergartens and ask for volunteers from participants enrolled in an Oxford University Clinical Research Unit Dengue birth cohort study (OXTREC approval 02-09) in District 8, HCMC. This birth cohort is an observational study.
Hand Foot and Mouth Disease
The Vietnamese Ministry of Health has a clinical grading system. Grade 1 disease is uncomplicated and are not admitted to hospital. Grade 2 and above are admitted to hospital with clinical features of neurological or systemic involvement. Grade 2 is split into Grade 2a and 2b depending if neurological manifestations such as myoclonus have been witnessed by the parents or by a health professional. In total, it is anticipated that 125 Grade 2a and 125 Grade 2b and 100 more severe Grade 3 and 4 will be recruited over one year. A subset who agree for brain magnetic resonance imaging (MRI) will also have a scan done during their hospital admission.
- Cognitive, language and motor development [ Time Frame: 18 months post discharge ]Measured by: Children 36 months and under at enrollment will use the translated and adapted Bayley Scales of Toddler and Infant Development 3rd Edition (Bayley III) for Vietnam. Children 48 months and above at enrollment will use the Vietnamese translation of Movement ABC-2 tool for their assessments. The children aged between 37 and 47 months at enrolment will have both assessments done at both visits.
- Neurological status [ Time Frame: 18 months post discharge ]Amiel-Tison Standardised neurological examination 0-6 years
- Abnormal Brain Image [ Time Frame: During hospital stay (estimate day 10) ]Magnetic resonance imaging of the brain of a subset of participants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066714
|Hospital of Tropical Diseases|
|Ho Chi Minh City, Vietnam|
|Principal Investigator:||Saraswathy Sabanathan, MRCPCH||Oxford University Clinical Reserach Unt, HCMC, Vietnam|