Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

Infant Development Clinical Trial

Official title:

Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04450056
• Other study ID #: 2020-3676-10314b
• Status: Active, not recruiting
• Start date: August 5, 2020
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk Collection
• Infant Development

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Pakistan	Matiari Research and Training Centre	Matiari	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	The Hospital for Sick Children, University of Toronto

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in breastmilk macronutrient composition		1 and 3 months postpartum
Primary	Change in breastmilk micronutrient composition		1 and 3 months postpartum
Secondary	Change in breastmilk bioactive composition		1 and 3 months postpartum
Secondary	Change in breastmilk microbiome		1 and 3 months postpartum
Secondary	Change in infant microbiome		1 and 3 months postpartum