Clinical trial NCT05516940: A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk
Official title: A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health
name: SAS Institute
name: Veeva Systems
First posted: 2022-08-26
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences in HMO from mothers' milk who delivered by Caesarean-section and normal vaginal deliveries.
timeFrame: baseline (no primary mothers' milk collection, but from existing human milk samples)
Secondary outcomes:
measure: Differences in human milk fat from mothers who delivered by Caesarean-section and normal vaginal deliveries.
timeFrame: baseline (no primary collection, but from existing human milk samples)
measure: Differences in human milk proteins from mothers who delivered by Caesarean-section and normal vaginal deliveries.
timeFrame: baseline (no primary collection, but from existing human milk samples)
measure: Differences in human milk gangliosides from mothers who delivered by Caesarean-section and normal vaginal deliveries.
timeFrame: baseline (no primary collection, but from existing human milk samples)
measure: Association of the differences in human milk composition with subject-reported outcomes
timeFrame: baseline (no primary collection, but from the existing questionnaires)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health
Study officials:
References: