A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Feeding, Milk, Human. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Longitudinal Prospective, Observational, Cohort Study in Lactating Mothers and Their Newborns to Further Unravel the Complexity of Human Milk
Overview
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.
Primary outcome measures
- Examples of exploratory outcome parameters in this study are the following human milk outcome parameters. [Time frame: 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. [Time frame: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Danone Nutricia Research — Utrecht
Identifiers
NCT: NCT05979532 · SBB21R&35943