A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 769
- 试验地点
- 1
- 主要终点
- Changes in infant length
研究概览
简要总结
This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.
详细描述
The relationship of breastmilk composition, the maternal gut microbiome and lifestyle factors such as diet, feeding practices and physical activity and the infant's health and gut microbiome will be investigated in this study.
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
- •Generally healthy mothers with the intention to breastfeed.
- •Aged 18 years and above.
- •Written informed consent.
- •Generally healthy term born (gestational age between 37 and 42 weeks).
- •Breastfed by their mothers, either exclusively or in combination with infant milk formula, at enrolment.
- •Chinese ethnicity of mother and father.
排除标准
- •Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
- •Difficulty to follow up and/or locate (e.g. known transfer to other hospitals, residing outside the city where the study site is located, or planning to move out of the current city; incapability of mothers to comply with study protocol or investigator' s uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.
- •Illegal drug use.
- •Regular smoking and/ or consumption of alcoholic beverages as per investigator's judgement.
- •A BMI of <18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy check around or before 16 weeks of gestational age.
- •Acute infectious disease or neoplastic disease or any kind of weakening or debilitating conditions (with history of positive, hepatitis C virus (HCV) or HIV serological test at any time during the pregnancy).
- •Presence of mastitis, fungal infections of the nipple or areola; reactivation of herpes simplex (HSV) or varicella zoster infection in the mammary or thoracic region at the time of enrolment.
- •Presence of chronic diseases such as endocrine, cardiovascular, renal, respiratory or hepatic diseases.
- •Presence of psychosis and severe post-partum depression.
- •Presence of autoimmune disease such as systemic lupus erythematosus, systemic scleroderma, ulcerative colitis, Crohn's disease, celiac disease.
- •Women whose health condition, according to the investigator's judgement, could interfere with the study conduction and assessment.
- •Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART).
- •Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
- •At enrolment, any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.
- •Consumption of food other than breast milk or infant formula.
- •Fully formula fed at enrolment.
结局指标
主要结局
Changes in infant length
时间窗: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Length measured in cm
Changes in human milk protein concentration
时间窗: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Protein concentration in g/l of human milk will be analyzed
Changes in infant head circumference
时间窗: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Head circumference measured in cm
Changes in human milk fat concentration
时间窗: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Fat concentration in g/l of human milk will be analyzed
Changes in human milk carbohydrate concentration
时间窗: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Carbohydrate concentration in g/l of human milk will be analyzed
Changes in human milk energy content
时间窗: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Energy content in kCal/l of human milk will be analyzed
Changes in infant weight
时间窗: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth
Weight measured in grams
次要结局
- Variations in human milk lipid composition(Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth)
- Changes in infant feeding practices(Data collected at 1 month, 3 month, 6 months, 12 months,2 years after infant birth)
- Changes in maternal body mass index(Data collected at 1 month, 3 month, 6 months, 12 months 2 years after infant birth)
- Variations in maternal fecal microbiome(Maternal fecal samples collected at 1 month, 3 month, 6 months, 12 months after infant birth)
- Variations in infant fecal microbiome(Infant fecal samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth)
- Variations in human milk microbiome(Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth)
- Variations in human milk micronutrients(Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth)
- Variations in human milk oligosaccharides (HMOs)(Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth)
- Changes in infant stool consistency and frequency(Data collected at 1 month, 3 month, 6 months, 12 months after infant birth)
- Variations in human milk amino acids and proteins(Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth)