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

Nutricia

Status: Enrolling

Conditions: Breast Feeding; Milk, Human

Study type: Observational

Funder types: Industry

Identifiers

NCT05979532

SBB21R&35943

Details and patient eligibility

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.

Enrollment: 172 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).