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

Healthy Clinical Trial

— ZoomMING  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05516940
• Other study ID #: 21.08.NR
• Status: Active, not recruiting
• Start date: May 6, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
China	Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health, SAS Institute, Veeva Systems

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Differences in human milk fat from mothers who delivered by Caesarean-section and normal vaginal deliveries.	Fatty acid will be analyzed by GC-FID	baseline (no primary collection, but from existing human milk samples)
Secondary	Differences in human milk proteins from mothers who delivered by Caesarean-section and normal vaginal deliveries.	Proteins will be analyzed by Ultra-high phase liquid chromatography	baseline (no primary collection, but from existing human milk samples)
Secondary	Differences in human milk gangliosides from mothers who delivered by Caesarean-section and normal vaginal deliveries.	gangliosides will be analyzed by GC-MS	baseline (no primary collection, but from existing human milk samples)
Secondary	Association of the differences in human milk composition with subject-reported outcomes	The subject-reported outcomes were existing information in the questionnaires	baseline (no primary collection, but from the existing questionnaires)