Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai (MuRu)
2015年2月5日 更新者:Dumex Baby Food Co., Ltd.
This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers.
Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their infants in their early phase of life which eventually will help to support breastfeeding.
研究概览
地位
未知
条件
研究类型
观察性的
注册 (预期的)
120
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Shanghai、中国
- Shanghai Children's Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
概率样本
研究人群
General health lactating mothers
描述
Inclusion Criteria:
- Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) whose birth weight is >10 and <90 percentiles gestational birth weight chart.
- Aged 20 - 40 years.
- Mothers who intend to exclusively breastfeed the infant for more than 6 weeks.
- Chinese ethnicity, including both parents.
- Mothers who sign the informed consent form in writing.
Exclusion Criteria:
Mothers:
- Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
- Difficult to follow up and/or locate (e.g. known transfer to other hospitals, residing outside Shanghai, plan to move out of Shanghai).
- Current smoker or having smoked during the pregnancy.
- Having consumed alcoholic drinks during pregnancy or lactation.
- Illegal drug abuser: cannabinoids (marijuana, hashish), stimulants (cocaine, amphetamine, methamphetamine), opioid (heroin, opium).
- Acute infection disease or neoplastic disease or any kind of weakening or debilitating conditions (no history of positive HBV, HCV or HIV serological test at any time during the pregnancy).
- Use of drug or pharmacologically active substances (e.g. herbal products, traditional medicine) to treat a particular disease or medical condition from the beginning of lactation ( those who consume herbal/traditional medicine for maintaining or improving well-being will still be included).
- 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 endocrinology diseases, particularly diabetes mellitus and gestational diabetes.
- Presence of obesity (pre-pregnancy BMI > 28).
- Presence of chronic diseases such as cardiovascular, renal, respiratory and 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 conduct and assessment.
- Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART).
- Elimination diet due to chronic allergic diseases or vegan.
- Incapability of subject 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.
Infants:
- Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Community Group
Chinese lactating mothers from community maternal & child healthcare centre
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VIP Group
Chinese lactating mothers from VIP clinics (maternal care center)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Breast milk composition
大体时间:0-42 day postpartum
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Human milk oligosaccharides profiles, fatty acids profile, macronutrients and energy content will be measured.
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0-42 day postpartum
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Growth
大体时间:0-42 day postpartum
|
Infant's anthropometrics (weight, length, head circumference).
|
0-42 day postpartum
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Maternal diet survey
大体时间:0-42 day postpartum
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Dietary macronutrients and energy intake, and food patterns will be assessed.
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0-42 day postpartum
|
Infection
大体时间:0-42 day postpartum
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Parent-reported infection patterns of infants during the observation period.
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0-42 day postpartum
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jing Li, professor、Shanghai Children's Medical Center Affiliated Shanghai Jiao Tong University, School of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年2月1日
初级完成 (预期的)
2015年8月1日
研究完成 (预期的)
2016年6月1日
研究注册日期
首次提交
2014年1月27日
首先提交符合 QC 标准的
2014年2月23日
首次发布 (估计)
2014年2月25日
研究记录更新
最后更新发布 (估计)
2015年2月9日
上次提交的符合 QC 标准的更新
2015年2月5日
最后验证
2015年2月1日
更多信息
与本研究相关的术语
其他研究编号
- HMR.1.C/A
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.