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

October 5, 2023 updated by: Société des Produits Nestlé (SPN)
The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 21.08.NR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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