A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk

Société des Produits Nestlé (SPN)1 site in 1 country250 target enrollmentMay 6, 2022

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 250
Locations: 1
Primary Endpoint: Differences in HMO from mothers' milk who delivered by Caesarean-section and normal vaginal deliveries.
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.

Detailed Description

The main objective of the study is to explore the differences in human milk composition from mothers delivering by Caesarean-section and normal vaginal deliveries. To further associate the differences found in human milk composition to infant outcomes.

Registry

clinicaltrials.gov

Start Date

May 6, 2022

End Date

July 30, 2023

Last Updated

5 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Human milk to be selected from the mothers who have delivered at full term (\>37 weeks of gestation).
•125 subjects will be selected who have delivered infants by Caesarean-section.
•125 subjects will be selected who have delivered infants by vaginal/normal deliveries.
•Subjects will be selected based on sample availability.
•Based on sample availability to balance by stage of lactation, geographical locations within China.
•Subjects of Han ethnicity.
•The collection of existing biological material and/or health-related personal data have been consented in the frame of the approved original study scope. We will propose to the participants to consent to this specific research.

Exclusion Criteria

•1\) Incomplete information either for the subject or the sample collected.

Outcomes

Primary Outcomes

Differences in HMO from mothers' milk who delivered by Caesarean-section and normal vaginal deliveries.

Time Frame: baseline (no primary mothers' milk collection, but from existing human milk samples)

HMO will be analyzed by HPLC-FLD

Secondary Outcomes

Differences in human milk fat from mothers who delivered by Caesarean-section and normal vaginal deliveries.(baseline (no primary collection, but from existing human milk samples))
Differences in human milk proteins from mothers who delivered by Caesarean-section and normal vaginal deliveries.(baseline (no primary collection, but from existing human milk samples))
Differences in human milk gangliosides from mothers who delivered by Caesarean-section and normal vaginal deliveries.(baseline (no primary collection, but from existing human milk samples))
Association of the differences in human milk composition with subject-reported outcomes(baseline (no primary collection, but from the existing questionnaires))