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Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

Sponsor
Aga Khan University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04450056
Collaborator
The Hospital for Sick Children (Other), University of Toronto (Other)
50
Enrollment
1
Location
3.9
Anticipated Duration (Months)
12.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants
Actual Study Start Date :
Aug 5, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Change in breastmilk macronutrient composition [1 and 3 months postpartum]

  2. Change in breastmilk micronutrient composition [1 and 3 months postpartum]

Secondary Outcome Measures

  1. Change in breastmilk bioactive composition [1 and 3 months postpartum]

  2. Change in breastmilk microbiome [1 and 3 months postpartum]

  3. Change in infant microbiome [1 and 3 months postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Matiari Research and Training Centre Matiari Sindh Pakistan

Sponsors and Collaborators

  • Aga Khan University
  • The Hospital for Sick Children
  • University of Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Zulfiqar Ahmed Bhutta, Founding Chair, Centre of Excellence in Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier:
NCT04450056
Other Study ID Numbers:
  • 2020-3676-10314b
First Posted:
Jun 29, 2020
Last Update Posted:
Nov 18, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2020