Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

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).

Study Overview

• Status: Unknown
• Conditions: Infant Development; Breast Milk Collection
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Matiari, Sindh, Pakistan
      • Matiari Research and Training Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Mothers and infants enrolled in the MaPPS Trial in Matiari District, Pakistan.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mother-infant pairs; 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).	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in breastmilk macronutrient composition	1 and 3 months postpartum
Change in breastmilk micronutrient composition	1 and 3 months postpartum

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in breastmilk bioactive composition	1 and 3 months postpartum
Change in breastmilk microbiome	1 and 3 months postpartum
Change in infant microbiome	1 and 3 months postpartum

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: The Hospital for Sick Children; University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-3676-10314b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Please contact the Primary Investigator directly for more details.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No