Evaluating long-term neurodevelopmental outcomes in Vietnamese and Indonesian children with Tuberculous meningitis

Funder:

OUCRU PSC 

Principal Investigators:

Julie Huynh 

Proposed Study Sites:

Pham Ngoc Thach Hospital, Ho Chi Minh City Vietnam

Children’s Hospital 2, Ho Chi Minh City Vietnam

Cipto Mangunkusumo Hospital, Jakarta Indonesia

Hasan Sadikin Hospital, Bandung Indonesia 

Background:

Neurological disability in children who survive TBM ranges from motor, sensory, cognitive to developmental deficits. Cognitive deficits has been found to occur in up to 80% of South African childhood survivors of TBM without accompanying motor deficits. For many childhood survivors of TBM, the majority of whom live in LMICs, severe illness results in significant neurodevelopmental sequelae. A meta-analysis on treatment outcomes in childhood TBM demonstrated neurological sequelae in 54% of survivors. However data on the physical, cognitive and behavioural sequelae of TBM, which have lasting socioeconomic implications for patients and their families, are limited and rarely include long-term follow-up. Children living with disabilities in LMICs are likely to experience poorer health and quality of life, reduced school participation and high rates of poverty when compared with their non-disabled peers, yet this has not been evaluated in TBM survivors. There is a lack of data in the literature on neurodevelopmental outcome post-TBM in children, in part due to lack of observational studies in this area but also inconsistent inclusion of outcome measures to quantify these deficits in clinical studies. These leads to a paucity of rehabilitative therapies for affected children and their caregivers, as well as burden at a socioeconomic level. Identifying and characterising neurodisability in children with TBM is one of the five pillars (i) prevention; (ii) diagnosis and treatment; (iii) surveillance; (iv) support and care for people affected by meningitis; and (v) advocacy and engagement outlined in the WHO defeating meningitis by 2030: Global Roadmap.

Primary Objectives:
Provide comprehensive neurodevelopmental training (using KABC-II) for local staff in Vietnam and Indonesia such that they are fully competent to use this neurodevelopmental assessment tool (NDAT) independently, accurately and consistently.
Ensure high quality, neurodevelopmental assessment data is collected, with minimal inter- and intra-individual variation in scoring, in children recovered from TBM.
Secondary Objectives:
Expanding our engagement with marginalised populations in our research by exploring the burden of care on families of childhood TBM survivors in order to develop tools that can support children and their families on discharge. This will be done through engagement activities conducted in each country:
A) an advisory group of children and carers that will advise on project conduct, patient information and ensure that community perspectives support the project;
B) formative research including interviews with children and carer(s)
C) Development of support material for carers and children on discharge (based on
needs heard through interviews and advisory groups). These will be created in
collaboration with the advisory groups.

Methods:
1) NDATs: i) Bayley scale of infant and toddler development (BSID) for children up to 2 years of age at time of commencement of anti-tuberculosis therapy (ATT) and ii) KABC-II for children from 2 to 16.5 years at time of commencement of ATT.
2) Cultural and linguistic adaptation of NDATs for Vietnam and Indonesia
4) Neurodevelopmental assessments to be performed at 48 and 72 weeks follow up appointments.
5) Sample size: 100 children in Indonesia and 50 in Vietnam (PediPOT) + anticipated 50 children from SURE. Total sample size = 200 [anticipated]
6) All severity of disease: stage I, II and III TBM disease at baseline will be included.
7) Raw scores will be used to compare outcome.

Timeline

: December 2026

Key Milestones / Activities

December 2026

Expected end and main results

2023

Start of enrolment and assessments

PELAJARI SELENGKAPNYA

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