Neurodevelopment Outcomes Following Severe Hand Foot and Mouth Disease in Vietnam
08RS
A Prospective Cohort Study Evaluating Prognostic Indicators and Sequelae Following Severe Hand Foot and Mouth Disease
1 other identifier
observational
243
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Typical duration for all trials
1 active site
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
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 4, 2016
October 1, 2016
1.5 years
February 14, 2014
October 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive, language and motor development
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.
18 months post discharge
Secondary Outcomes (1)
Neurological status
18 months post discharge
Other Outcomes (1)
Abnormal Brain Image
During hospital stay (estimate day 10)
Study Arms (2)
Healthy Cohort
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.
Eligibility Criteria
Hand foot and mouth disease patients admitted to Hospital of Tropical Diseases. Healthy children form 3 kindergartens in District 8, HCMC and infants enrolled in Dengue Birth cohort (Oxtrec 02-09)
You may qualify if:
- Hospitalized children ≤ 4 years admitted with HFMD at Hospital for Tropical Diseases (HTD)
- Parents or legal guardians must give informed consent for their child to participate.
You may not qualify if:
- Ex-premature children
- Any prior chronic illness whether required hospitalization or not
- Previous Pediatric Intensive Care Unit (PICU) admission/ventilation including during neonatal period
- Prior learning disability or neurological regression
- Healthy cohort
- Child age ≤ 4 years
- Parents or legal guardians must give informed consent for their child to participate.
- Ex-premature children
- Any prior chronic illness whether required hospitalization or not
- Previous PICU admission/ventilation including during neonatal period
- Prior learning disability or neurological regression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of Tropical Diseases
Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saraswathy Sabanathan, MRCPCH
Oxford University Clinical Reserach Unt, HCMC, Vietnam
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 19, 2014
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
August 1, 2016
Last Updated
October 4, 2016
Record last verified: 2016-10