A longitudinal prospective, observational, cohort study in lactating mothers and their newborns to further unravel the complexity of human milk - White Gold

utricia Research0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年4月9日

试验速览

暂无简介。

•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).

发起方

utricia Research