Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

NCT04450056 | Unknown

• 1 other identifier: 2020-3676-10314b
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Milk Collection; Infant Development

Outcome Measures

Primary Outcomes (2)

• Change in breastmilk macronutrient composition

  1 and 3 months postpartum

• Change in breastmilk micronutrient composition

  1 and 3 months postpartum

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

Mother-infant pairs

Eligibility Criteria

• Age: 15 Years - 25 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• The Hospital for Sick Children: collaborator
• University of Toronto: collaborator

Study Sites (1)

Matiari Research and Training Centre

Matiari, Sindh, Pakistan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breastmilk sample Rectal swab

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Chair, Centre of Excellence in Women and Child Health

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 29, 2020
• Study Start: August 5, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)