Improving infant Neurocognitive Development and Growth Outcomes with micronutrients (INDiGO): A protocol for an
Sophie E Moore1,2, Samantha McCann1, Ousman Jarjou2
1Department of Women and Children's Health, King's College London, London, England, UK.
Insights
Early life micronutrient supplementation is crucial for infant development. This study investigates the most effective way to improve infant micronutrient status and its impact on development in rural Gambia.
Area of Science:
- Public Health and Nutrition
- Maternal and Child Health
- Developmental Pediatrics
Background:
- Early life undernutrition irreversibly impacts child growth and cognitive development.
- Existing interventions often fail due to lack of early infant nutritional support.
- Micronutrient deficiencies and developmental deficits begin before six months of age.
Purpose of the Study:
- To identify the most efficacious micronutrient supplementation strategy for infants.
- To assess the impact of supplementation on infant development and neurocognitive outcomes.
- To provide evidence for future policy and intervention trials.
Main Methods:
- A five-arm, double-blind, placebo-controlled randomized trial in rural Gambia.
- 600 pregnant women enrolled, receiving supplementation during pregnancy and/or lactation.
- Infants supplemented from Day 8 to six months; primary outcome is infant brain development at six months.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This research will establish the most effective method for enhancing infant micronutrient status.
- Findings will inform policy and future trials on infant development and nutrition.
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).
