Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan

Not Applicable

Completed

• Conditions: Breast Milk Collection; Infant Development

• Registration Number: NCT04451395
• Lead Sponsor: Aga Khan University

Brief Summary

Breastmilk is considered optimal for infant growth and development. However, evidence suggests that breastmilk composition can vary according to maternal nutritional status. Among women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies. As well, the prevalence of early stunting among Pakistani infants is high. Using a hypothesized pathway model, this study will assess pathways between maternal nutritional status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Study Start: 2020-08-05
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

Inclusion Criteria

• Enrolled in the MaPPS Trial
• Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
• The infant must be term-born (>37 weeks gestation)
• Infant must be 3 months ± 30 days old at the time of recruitment
• Mothers must be willing to provide a complete breastmilk expression from one breast
• Intervention arm only: mother reports compliance with study-administered MMN supplements at least 50% of the time (i.e., 4 out of 7 days per week)
• Able to provide informed consent

Exclusion Criteria

• Mother reports mixed feeding in her infant with nutritive feeds (i.e., any provision of formula or animal milk)
• The infant was born preterm (earlier than 37 weeks gestation)
• Mother does not wish to provide a complete breast expression of one breast
• Intervention arm: mother reports compliance with MMN supplements <50% of the time

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal BMI	3 months postpartum
Maternal dietary diversity score	3 months postpartum	Minimum score: 0, maximum score: 10
Maternal hemoglobin concentration	3 months postpartum
Maternal supplement adherence	3 months postpartum	Determined by report (options: 0, 25, 50, 75, or 100%)
Breastmilk macronutrient composition	3 months postpartum
Breastmilk micronutrient composition	3 months postpartum
Infant length	3 months postpartum

Secondary Outcome Measures

Name	Time	Method
Infant weight	3 months postpartum
Infant middle-upper arm circumference	3 months postpartum
Infant head circumference	3 months postpartum
Breastmilk bioactive composition	3 months postpartum
Breastmilk microbiome	3 months postpartum
Infant microbiome	3 months postpartum

Trial Locations

Locations (1)

Matiari Research and Training Centre; 🇵🇰 Matiari, Sindh, Pakistan