A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk

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).