A Study in Lactating Mothers and Their Newborns to Analys... | NCT05979532

Studies
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk

NCT05979532

Sponsor

Nutricia Research

Status

Recruiting

Last Update Posted

Mar 15, 2024Actual

Enrollment

172Estimated

Phase

Not provided

Conditions

Breast Feeding
Milk, Human

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2024Actual

Primary Completion Date

Aug 31, 2027Estimated

Completion Date

Aug 31, 2027Estimated

First Submitted Date

Jul 31, 2023

First Submission Date that Met QC Criteria

Jul 31, 2023

First Posted Date

Aug 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk groups, and in relation to maternal, perinatal, infant, and sample characteristics as well as to the microbiota of the infant.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

172Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Examples of exploratory outcome parameters in this study are the following human milk outcome parameters.	Laboratory analyses of Human Milk Oligosaccharides (HMOs), proteins, amino acids, lipids, and fatty acids.	at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.	Laboratory analyses of Infant's faecal microbiome composition.	at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women in the third trimester of pregnancy (≥28 weeks) who have the intention to provide breastfeeding for at least 6 months post-partum.
Age ≥ 18 years.
Willingness to provide residual human milk.
Living in proximity of NCRU (clinical site in NL).
Dutch speaking and reading.
Freezer -18°C available.
Having mobile phone, tablet, or computer available.
Signed informed consent from the subject (pregnant woman).
Signed informed consent from the other parent and/or legally acceptable representative, of the unborn baby(s), aged ≥ 18 years.

Exclusion Criteria:

Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
Multiple pregnancy > 2.
Incapability of subjects to comply with study protocol as per the judgment of the site staff (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection).
Women (and their unborn baby(s)) with current or intended participation in any other clinical study involving investigational or marketed products.
Employees and/or children/family members or relatives of employees of Nutricia Research or the participating site.

Continuation exclusion criteria (after birth)

Stillbirth
Newborn having any congenital abnormality, chromosomal disorder or severe disease that would prevent the infant from breastfeeding and/or growing normally based on the opinion of a health care professional and/or study physician.
No donation of any milk sample within the first 8 weeks postpartum (timepoints week 1, week 1.5, and week 4).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

The study population consists of lactating mothers and their newborn.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

120 Lactating mothers who have the intention to breastfeed for at least 6 months and their newborns.

Sampling Method

Non-Probability Sample

ID	Term
D005247	Feeding Behavior
D001519	Behavior