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

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT05516940
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2022-05-06
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

1. Human milk to be selected from the mothers who have delivered at full term (>37 weeks of gestation).
2. 125 subjects will be selected who have delivered infants by Caesarean-section.
3. 125 subjects will be selected who have delivered infants by vaginal/normal deliveries.
4. Subjects will be selected based on sample availability.
5. Based on sample availability to balance by stage of lactation, geographical locations within China.
6. Subjects of Han ethnicity.
7. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in HMO from mothers' milk who delivered by Caesarean-section and normal vaginal deliveries.	baseline (no primary mothers' milk collection, but from existing human milk samples)	HMO will be analyzed by HPLC-FLD

Secondary Outcome Measures

Name	Time	Method
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)	Fatty acid will be analyzed by GC-FID
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)	Proteins will be analyzed by Ultra-high phase liquid chromatography
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)	gangliosides will be analyzed by GC-MS
Association of the differences in human milk composition with subject-reported outcomes	baseline (no primary collection, but from the existing questionnaires)	The subject-reported outcomes were existing information in the questionnaires

Trial Locations

Locations (1)

Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health; 🇨🇳 Beijing, China