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

Société des Produits Nestlé (SPN)250 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

250

Conditions

Healthy

Interventions

OTHER

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

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

Beijing, China

Outcomes

Primary Outcomes

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

HMO will be analyzed by HPLC-FLD

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

Secondary Outcomes

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

Fatty acid will be analyzed by GC-FID

Time frame: 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.

Proteins will be analyzed by Ultra-high phase liquid chromatography

Time frame: 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.

gangliosides will be analyzed by GC-MS

Time frame: baseline (no primary collection, but from existing human milk samples)

Association of the differences in human milk composition with subject-reported outcomes

The subject-reported outcomes were existing information in the questionnaires

Time frame: baseline (no primary collection, but from the existing questionnaires)

Data from ClinicalTrials.gov

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