Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

• Conditions: Breast Milk Collection; Infant Development
• Interventions: Other: No intervention

• Registration Number: NCT04450056
• Lead Sponsor: Aga Khan University

Brief Summary

In Pakistan, breastfeeding is widely practiced. National data suggests that 94% of infants \<2 years of age receive breastmilk at some point. However, the introduction of complementary foods often occurs early. At 3 months of age, it is suggested that only 54% of Pakistani infants are exclusively breastfed. This declines with each month of age. Because the production and release of breastmilk is influenced by the frequency and intensity of suckling, early initiation of complementary feeding can reduce breastmilk output. Given that complementary foods are introduced early within Pakistan, we hypothesize that breastmilk composition will change between 1 and 3 months postpartum among those mother-infant pairs if nutritive complementary foods are introduced early (i.e., before 6 months). In this study, we aim to better understand how breastmilk composition changes over time among infants recruited at 1 month of age who are exclusively breastfed or receive only non-nutritive feeds. 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: 2020-06-29
• Study Start: 2020-08-05
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-18
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 1 month + 14 days old at the time of recruitment
• Mothers must be willing to provide a complete breastmilk expression from one breast (either via breast pump or hand expression)
• Able to provide informed consent

Exclusion Criteria

• Mother reports mixed feeding of 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mother-infant pairs	No intervention	Mothers with a term-born (\>37 weeks gestation) infant whom they are exclusively or predominantly breastfeeding at 1 month postpartum. Mothers must be enrolled in the MaPPS Trial (ClinicalTrials.gov Identifier: NCT03287882).

Primary Outcome Measures

Name	Time	Method
Change in breastmilk micronutrient composition	1 and 3 months postpartum
Change in breastmilk macronutrient composition	1 and 3 months postpartum

Secondary Outcome Measures

Name	Time	Method
Change in infant microbiome	1 and 3 months postpartum
Change in breastmilk bioactive composition	1 and 3 months postpartum
Change in breastmilk microbiome	1 and 3 months postpartum

Trial Locations

Locations (1)

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