A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNutricia Research
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov