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Trial record 2 of 5 for:    Open Studies | "Hand, Foot and Mouth Disease"

Neurodevelopment Outcomes Following Severe Hand Foot and Mouth Disease in Vietnam (08RS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Oxford University Clinical Research Unit, Vietnam
Sponsor:
Collaborators:
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Children's Hospital 1, Ho Chi Minh City, Viet Nam
Preventative Medical Centre, District 8, Ho Chi Minh City, Vietnam
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT02066714
First received: February 14, 2014
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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
Hand Foot and Mouth Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Cohort Study Evaluating Prognostic Indicators and Sequelae Following Severe Hand Foot and Mouth Disease

Resource links provided by NLM:


Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:
  • Cognitive, language and motor development [ Time Frame: 18 months post discharge ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Neurological status [ Time Frame: 18 months post discharge ] [ Designated as safety issue: No ]
    Amiel-Tison Standardised neurological examination 0-6 years


Other Outcome Measures:
  • Abnormal Brain Image [ Time Frame: During hospital stay (estimate day 10) ] [ Designated as safety issue: No ]
    Magnetic resonance imaging of the brain of a subset of participants


Estimated Enrollment: 500
Study Start Date: June 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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)

Criteria
  1. HFMD:

    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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
  2. Healthy cohort

Inclusion Criteria:

  • Child age ≤ 4 years
  • Parents or legal guardians must give informed consent for their child to participate.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066714

Contacts
Contact: Saraswathy Sabanathan, MRCPCH 0084906741371 swhitehorn@oucru.org

Locations
Vietnam
Hospital of Tropical Diseases Recruiting
Ho Chi Minh City, Vietnam
Contact: Qui Tu Phan, Dr         
Contact: Laura Merson         
Principal Investigator: Phan Tu Qui, MD         
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Children's Hospital 1, Ho Chi Minh City, Viet Nam
Preventative Medical Centre, District 8, Ho Chi Minh City, Vietnam
Investigators
Principal Investigator: Saraswathy Sabanathan, MRCPCH Oxford University Clinical Reserach Unt, HCMC, Vietnam
  More Information

No publications provided

Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT02066714     History of Changes
Other Study ID Numbers: 08RS
Study First Received: February 14, 2014
Last Updated: February 17, 2014
Health Authority: Vietnam: Ho Chi Minh City Health Service

Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Enterovirus Infections
Hand, Foot and Mouth Disease
Coxsackievirus Infections
Herpangina
Cognition
Neurocognitive
Sequelae
Outcomes

Additional relevant MeSH terms:
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Coxsackievirus Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Stomatognathic Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014