A longitudinal prospective, observational, cohort study in lactating mothers and their newborns to further unravel the complexity of human milk
- Conditions
- studie met gezonde vrijwilligersNot applicable
- Registration Number
- NL-OMON53220
- Lead Sponsor
- utricia Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
1. Pregnant women in the third trimester of pregnancy (>=28 weeks) who have the
intention to provide breastfeeding for at least 6 months post-partum
2. Age >= 18 years
3. Willingness to provide residual human milk
4. Located in proximity of NCRU
5. Dutch speaking and reading
6. Freezer -18°C available
7. Having mobile phone, tablet, or computer available
8. Signed informed consent from subject (pregnant woman)
9. Signed informed consent from the other parent and/or legally acceptable
representative of the unborn baby(s), aged >= 18 years.
1. Pregnant women known positive for human immunodeficiency virus (HIV),
hepatitis B (HBV) or hepatitis C (HCV) (self-reported). 2. Multiple pregnancy
(more than 2). 3. Incapability of subjects to comply with study protocol as per
the judgment of the study staff (e.g. fluency in local language, access to
laptop/smartphone devices and internet connection required for data
collection). 4. Women (and their unborn baby(s)) with current or intended
participation in any other clinical study involving investigational or marketed
products. 5. Employees and/or children/family members or relatives of employees
of Nutricia Research or the participating site. After enrolment the following
continuation criteria will lead to discontinuation of the study. 1. Still
birth. 2. Newborn having any congenital abnormality, chromosomal disorder or
severe disease that would prevent the infant from breastfeeding and growing
normally based on the opinion of a health care professional and/or study
physician. 3. No donation of any milk sample within the first 8 weeks
postpartum (timepoints week 1, week 1.5, and week 4).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Outcome parameters:<br /><br>Examples of the exploratory outcome parameters in this study are the following<br /><br>human milk outcome parameters at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104:<br /><br>* Proteins<br /><br>* Amino acids<br /><br>* Lipids<br /><br>* Fatty acids<br /><br><br /><br><br /><br>The following exploratory faecal outcome parameter at Day 3 and at Week 1.5, 4,<br /><br>10, 26, 52, and 104 will be analysed if sufficient faecal samples are collected:<br /><br>* Infant*s faecal microbiome composition</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>