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

NCT05516940 | Completed

• 1 other identifier: 21.08.NR
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  HMO will be analyzed by HPLC-FLD

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

Secondary Outcomes (4)

• 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)

Study Arms (2)

Caesarean-section

125 subjects will be selected who have delivered infants by Caesarean-section.

Normal delivery

125 subjects will be selected who have delivered infants by vaginal/normal deliveries

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population of interest is mothers that have delivered at full term (\>37 weeks of gestation) who have already provided human milk samples collected within China CDC's cross sectional multi-centric human milk study conducted in China.

You may qualify if:

• Human milk to be selected from the mothers who have delivered at full term (\>37 weeks of gestation).
• subjects will be selected who have delivered infants by Caesarean-section.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Veeva Systems: collaborator
• Société des Produits Nestlé (SPN): lead
• SAS Institute: collaborator
• Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health: collaborator

Study Sites (1)

Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

human milk samples have already been collected within China CDC's cross sectional multi-centric human milk study conducted in China

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 26, 2022
• Study Start: May 6, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)