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

Background

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.

Methods

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.

Discussion

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.

Trial registration

ISRCTN registry ( ISRCTN15063705, 09/07/2021); Pan African Clinical Trials Registry ( PACTR202201552774601, 21/01/2022).

Deficiencies of micronutrients in infants and young children can have a long-lasting impact on growth and development. This is especially relevant in populations with poor diets. However, little research has focused on interventions to improve micronutrient deficiencies in the first six-months of life, during the period when exclusive breastfeeding is recommended. Here we describe the protocol for a randomised trial among women and infants living in sub-Saharan Africa, to determine whether supplementation with micronutrients to mothers (in pregnancy, or pregnancy and lactation) or supplementation to infants directly (while promoting exclusive breastfeeding) will improve infant development across the first 12 months of life. This trial will test the effect of supplementation on infant brain development, micronutrient status and growth. This novel research will determine the best way to improve infant micronutrient status and developmental outcomes, providing important data for policy considerations.

Informations de copyright

Copyright: © 2024 Moore SE et al.

Déclaration de conflit d'intérêts

No competing interests were disclosed.