NL-OMON53220
Recruiting
Not Applicable
A longitudinal prospective, observational, cohort study in lactating mothers and their newborns to further unravel the complexity of human milk - White Gold
utricia Research0 sites120 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- utricia Research
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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