Status:
RECRUITING
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
Lead Sponsor:
Nutricia Research
Conditions:
Breast Feeding
Milk, Human
Eligibility:
FEMALE
18+ years
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,...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT05979532
Start Date
February 13 2024
End Date
August 31 2027
Last Update
March 15 2024
Active Locations (1)
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1
Danone Nutricia Research
Utrecht, Netherlands, 3584CT