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Predicting neurodevelopmental risk in children born to mothers living with HIV in Kenya: protocol for a prospective
Eren Oyungu1,2, Ola El Kebbi3, Rachel Vreeman2,4
1Department of Medical Physiology, Moi University College of Health Sciences, Eldoret, Kenya.
Insights
This study identifies risk factors for neurodevelopmental outcomes in children exposed to HIV and antiretrovirals. A risk assessment tool will be developed to predict adverse outcomes in infants up to 24 months.
Area of Science:
- Pediatric Neurodevelopment
- HIV/AIDS Research
- Longitudinal Cohort Studies
Background:
- Children exposed to HIV and antiretrovirals face uncertain neurodevelopmental risks.
- Identifying predictive factors for neurodevelopmental outcomes is crucial.
Purpose of the Study:
- To determine risk factors predicting neurodevelopmental outcomes in children up to 24 months.
- To develop a risk assessment tool for identifying at-risk children.
Main Methods:
- Prospective longitudinal cohort study of 1000 infants (500 HIV-exposed, 500 unexposed) in Kenya.
- Bi-annual measurement of infectious morbidity and biological/sociodemographic/psychosocial factors.
- Neurodevelopmental assessment at 24 months using Child Behaviour Checklist and Bayley Scales.
Main Results:
- Analysis will quantify associations between risk factors and neurodevelopmental outcomes.
- A predictive risk assessment tool will be created for children up to 24 months.
Conclusions:
- The study will elucidate key predictors of neurodevelopmental outcomes in HIV-exposed children.
- Findings will inform targeted interventions and support for at-risk infants.
Introduction:
For the growing number of children with in utero and postpartum exposure to HIV and/or antiretrovirals, it is unclear which exposures or risk factors play a significant role in predicting worse neurodevelopmental outcomes. This protocol describes a prospective longitudinal cohort study of infants born to mothers living with HIV and those born to mothers without HIV. We will determine which risk factors are most predictive of child neurodevelopment at 24 months. We aim to create a risk assessment tool to help predict which children are at risk for worse neurodevelopment outcomes.
Methods And Analysis:
This study leverages an existing Kenyan cohort to prospectively enrol 500 children born to mothers living with HIV and 500 to those without HIV (n=1000 total) and follow them from birth to age 24 months. The following factors will be measured every 6 months: infectious morbidity and biological/sociodemographic/psychosocial risk factors. We will compare these factors between the two groups. We will then measure and compare neurodevelopment within children in both groups at 24 months of age using the Child Behaviour Checklist and the Bayley Scales of Infant and Toddler Development, third edition. Finally, we will use generalised linear mixed modelling to quantify associations with neurodevelopment and create a risk assessment tool for children ≤24 months.
Ethics And Dissemination:
The study is approved by the Moi University's Institutional Research and Ethics Committee (IREC/2021/55; Approval #0003892), Kenya's National Commission for Science, Technology and Innovation (NACOSTI, Reference #700244) and Indiana University's Institutional Review Board (IRB Protocol #110990). This study carries minimal risk to the children and their mothers, and all mothers will provide written consent for participation in the study. Results will be disseminated to maternal child health clinics within Uasin Gishu County, Kenya and via papers submitted to peer-reviewed journals and presentation at international conferences.
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