A Longitudinal Prospective, Observational, Cohort Study in Lactating Mothers and Their Newborns to Further Unravel the Complexity of Human Milk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
- •Multiple pregnancy >
- •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).
结局指标
主要结局
The following exploratory faecal outcome parameter will be analysed if sufficient faecal samples are collected.
时间窗: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
Laboratory analyses of Infant's faecal microbiome composition.
Examples of exploratory outcome parameters in this study are the following human milk outcome parameters.
时间窗: at Day 3 and at Week 1.5, 4, 10, 26, 52, and 104 postpartum.
Laboratory analyses of Human Milk Oligosaccharides (HMOs), proteins, amino acids, lipids, and fatty acids.
次要结局
未报告次要终点