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Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

NCT ID: NCT04450056

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-05

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Breast Milk Collection Infant Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Dr Zulfiqar Ahmed Bhutta

Founding Chair, Centre of Excellence in Women and Child Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Matiari Research and Training Centre

Matiari, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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2020-3676-10314b

Identifier Type: -

Identifier Source: org_study_id