Actively Recruiting
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
Led by Nutricia Research · Updated on 2024-03-15
172
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women in the third trimester (28 weeks or more) intending to breastfeed for at least 6 months postpartum
- Age 18 years or older
- Willingness to provide leftover human milk samples
- Living near the clinical site in the Netherlands
- Able to read and speak Dutch
- Have a freezer at -18°C available
- Have access to a mobile phone, tablet, or computer
- Signed informed consent from the pregnant woman
- Signed informed consent from the other parent or legal representative of the unborn baby, aged 18 years or older
You will not qualify if you...
- Pregnant women positive for HIV, hepatitis B, or hepatitis C
- Multiple pregnancy with more than two babies
- Unable to follow the study protocol, including language or device access issues
- Participation in any other clinical study involving investigational or marketed products
- Employees or family members of employees of Nutricia Research or the study site
- Stillbirth after birth
- Newborns with congenital abnormalities, chromosomal disorders, or severe diseases preventing breastfeeding or normal growth
- No milk donation within the first 8 weeks postpartum (weeks 1, 1.5, and 4)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Danone Nutricia Research
Utrecht, Netherlands, 3584CT
Actively Recruiting
Research Team
D
Danone Nutricia Research N Research
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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