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Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia

Sophie E Moore Orcid Logo, Samantha McCann, Ousman Jarjou, Muhammed A Danjo Orcid Logo, Bakary Sonko Orcid Logo, Ebrima Sise, Samuel Beaton, Daniel Tod, Greg Fegan, Andrew M Prentice

Wellcome Open Research, Volume: 9, Start page: 377

Swansea University Authors: Daniel Tod, Greg Fegan

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DOI (Published version): 10.12688/wellcomeopenres.21282.1

Abstract

Undernutrition during the early years of life has a harmful and irreversible impact on child growth and cognitive development. Many of the interventions tested to improve outcomes across infancy have had disappointing or inconsistent impact, a common feature being the absence of any attempt to provi...

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Published in: Wellcome Open Research
ISSN: 2398-502X
Published: F1000 Research Limited 2024
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URI: https://cronfa.swan.ac.uk/Record/cronfa68101
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The primary outcome will be infant brain development at six months, with micronutrient status, growth and neurocognitive development to 12 months as secondary outcomes. This novel research will identify the most efficacious way of improving micronutrient status in infancy, and assess impact on infant developmental outcomes, providing an evidence base for future effectiveness trials and policy recommendations. ISRCTN registry ( ISRCTN15063705, 09/07/2021); Pan African Clinical Trials Registry ( PACTR202201552774601, 21/01/2022). 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spelling 2024-10-29T14:23:55.7706113 v2 68101 2024-10-29 Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia fbb6764a346f9e12b7978d67130240f7 Daniel Tod Daniel Tod true false a9005418b89918776f3d8895ba42e850 Greg Fegan Greg Fegan true false 2024-10-29 MEDS Undernutrition during the early years of life has a harmful and irreversible impact on child growth and cognitive development. Many of the interventions tested to improve outcomes across infancy have had disappointing or inconsistent impact, a common feature being the absence of any attempt to provide nutritional supplements to infants during the first six months. With increasing evidence of micronutrient deficiencies in this age group, alongside strong evidence that growth and developmental deficits begin before six months, a renewed focus on the micronutrient status of infants is required. This study is a five-arm, double-blind, placebo-controlled, randomised efficacy trial of micronutrient supplementation to mothers (during pregnancy or pregnancy and lactation) and infants (Day 8 to six months of age) in rural Gambia, where rates of micronutrient deficiencies are high. 600 pregnant women (<20 weeks gestation) will be enrolled into one of five trial arms and followed to 12 months post-partum. The primary outcome will be infant brain development at six months, with micronutrient status, growth and neurocognitive development to 12 months as secondary outcomes. This novel research will identify the most efficacious way of improving micronutrient status in infancy, and assess impact on infant developmental outcomes, providing an evidence base for future effectiveness trials and policy recommendations. ISRCTN registry ( ISRCTN15063705, 09/07/2021); Pan African Clinical Trials Registry ( PACTR202201552774601, 21/01/2022). [Abstract copyright: Copyright: © 2024 Moore SE et al.] Journal Article Wellcome Open Research 9 377 F1000 Research Limited 2398-502X Micronutrients, pregnancy, lactation, infancy, neurodevelopment, growth, intervention, Gambia 16 7 2024 2024-07-16 10.12688/wellcomeopenres.21282.1 Study protocol COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University External research funder(s) paid the OA fee (includes OA grants disbursed by the Library) The INDiGO trial is funded by Wellcome, through a Senior Research Fellowship to the lead author (SEM; grant reference 220225). The trial will benefit from the infrastructure already in place at MRCG which is funded by the UK Medical Research Council (MRC) and the Department for International Development (DFID) under the MRC/DFID Concordat agreement. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. 2024-10-29T14:23:55.7706113 2024-10-29T13:52:28.9883747 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Health Data Science Sophie E Moore 0000-0003-1650-3238 1 Samantha McCann 2 Ousman Jarjou 3 Muhammed A Danjo 0009-0007-6811-0301 4 Bakary Sonko 0000-0003-3822-2680 5 Ebrima Sise 6 Samuel Beaton 7 Daniel Tod 8 Greg Fegan 9 Andrew M Prentice 10 68101__32779__c6d0c29a7c9248148e7650c3e9f87445.pdf 68101.VOR.pdf 2024-10-29T14:15:25.1248932 Output 767137 application/pdf Version of Record true © 2024 Moore SE et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0). true eng http://creativecommons.org/licenses/by/4.0/
title Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia
spellingShingle Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia
Daniel Tod
Greg Fegan
title_short Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia
title_full Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia
title_fullStr Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia
title_full_unstemmed Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia
title_sort Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an efficacy trial in rural Gambia
author_id_str_mv fbb6764a346f9e12b7978d67130240f7
a9005418b89918776f3d8895ba42e850
author_id_fullname_str_mv fbb6764a346f9e12b7978d67130240f7_***_Daniel Tod
a9005418b89918776f3d8895ba42e850_***_Greg Fegan
author Daniel Tod
Greg Fegan
author2 Sophie E Moore
Samantha McCann
Ousman Jarjou
Muhammed A Danjo
Bakary Sonko
Ebrima Sise
Samuel Beaton
Daniel Tod
Greg Fegan
Andrew M Prentice
format Journal article
container_title Wellcome Open Research
container_volume 9
container_start_page 377
publishDate 2024
institution Swansea University
issn 2398-502X
doi_str_mv 10.12688/wellcomeopenres.21282.1
publisher F1000 Research Limited
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Health Data Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Health Data Science
document_store_str 1
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description Undernutrition during the early years of life has a harmful and irreversible impact on child growth and cognitive development. Many of the interventions tested to improve outcomes across infancy have had disappointing or inconsistent impact, a common feature being the absence of any attempt to provide nutritional supplements to infants during the first six months. With increasing evidence of micronutrient deficiencies in this age group, alongside strong evidence that growth and developmental deficits begin before six months, a renewed focus on the micronutrient status of infants is required. This study is a five-arm, double-blind, placebo-controlled, randomised efficacy trial of micronutrient supplementation to mothers (during pregnancy or pregnancy and lactation) and infants (Day 8 to six months of age) in rural Gambia, where rates of micronutrient deficiencies are high. 600 pregnant women (<20 weeks gestation) will be enrolled into one of five trial arms and followed to 12 months post-partum. The primary outcome will be infant brain development at six months, with micronutrient status, growth and neurocognitive development to 12 months as secondary outcomes. This novel research will identify the most efficacious way of improving micronutrient status in infancy, and assess impact on infant developmental outcomes, providing an evidence base for future effectiveness trials and policy recommendations. ISRCTN registry ( ISRCTN15063705, 09/07/2021); Pan African Clinical Trials Registry ( PACTR202201552774601, 21/01/2022). [Abstract copyright: Copyright: © 2024 Moore SE et al.]
published_date 2024-07-16T05:24:34Z
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