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Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04450056
Enrollment
50
Registered
2020-06-29
Start date
2020-08-05
Completion date
2020-12-31
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Milk Collection, Infant Development

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).

Interventions

OTHERNo intervention

No intervention

Sponsors

The Hospital for Sick Children
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
Aga Khan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in breastmilk macronutrient composition1 and 3 months postpartum
Change in breastmilk micronutrient composition1 and 3 months postpartum

Secondary

MeasureTime frame
Change in breastmilk bioactive composition1 and 3 months postpartum
Change in breastmilk microbiome1 and 3 months postpartum
Change in infant microbiome1 and 3 months postpartum

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026