Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 5, 2025
Open Peer Review Period: Jun 5, 2025 - Jul 31, 2025
Date Accepted: Jan 5, 2026
Date Submitted to PubMed: Jan 6, 2026
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Early life exposures, neurodevelopment, and health outcomes – a study protocol.
ABSTRACT
Background Negative early-life exposures, particularly during the golden first 1000 days, may compromise organ development and cause life-long negative consequences. This paper provides a comprehensive overview of a cohort study, underpinned by an exposome and deep-phenotyping framework, aiming to identify potential consequences of exposures, including environmental pollutants during pregnancy and infancy, on child health and development. Methods The study will utilize an ongoing pregnancy cohort with 800 mother-infant pairs in Bhaktapur, Nepal. This cohort is nested within a randomized controlled trial (RCT), which investigated daily vitamin B12 supplementation commencing at ca. 15 weeks of pregnancy up to 6 months postpartum (registered with ClinicalTrials.gov, NCT03071666). The primary outcomes in the RCT were linear growth and neurodevelopment at 12 months of age. Within this project, all children will have reached school age, at which time more reliable estimates of neurodevelopmental outcomes and other health outcomes reflecting future health can be obtained. The study will include the following outcomes: neurodevelopment, vaccine response, thyroid function, growth and body composition, markers of metabolic illnesses, and lung function. Biochemical analyses will include the measurement of environmental pollutants, targeted metabolomics, vitaminomics, epigenetics, and leucocyte telomere lengths. Discussion The current study includes using a well-characterized mother-child cohort in a South Asian setting with repeated biological samples from blood, breast milk, and urine and a wide array of high-quality longitudinal data on health, growth, and neurodevelopment. Using these data, our ambition is to provide a deeper understanding of the interplay between environmental pollutants, nutrition, inflammation, and health outcomes to inform guidelines and interventions to protect vulnerable women and children in marginalized settings.
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.