Human Milk Nutrients and Infants' Health Outcomes in South China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The growth of children
Study Overview
Brief Summary
The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.
Detailed Description
Human milk components are beneficial to the growth and development of infants, such as phospholipids, gangliosides, sialic acids, choline, oligosaccharide and so on. However, studies on the associations between human milk components and infants' outcomes are limited. Therefore, this study is designed to investigate the relationship between Chinese human milk components and the growth and development of infants.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 4 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 4-5 years
- •healthy children
- •breastfeeding between 0 to 400 days of age
- •human milk components in human milk being determined
- •sign informed consent
Exclusion Criteria
- •children with severe chronic diseases, such as tumor, severe digestive diseases, kidney diseases
- •gestational diabetes, hypertension and other metabolic diseases
- •children with mental system diseases
- •children with congenital and genetic diseases
- •children with infectious diseases, eg, upper respiratory tract infection or diarrhea
- •antibiotic or other drugs influencing intestinal flora being taken within 45 days
- •Withdraw withdraw informed consent serious violation of the scheme no longer meet the research criteria because of health factors or accidents
Outcomes
Primary Outcomes
The growth of children
Time Frame: 18 month
The physical growth and body composition of children will be checked by physical examination.
The cognitive development of children
Time Frame: 18 month
The brain developments of children will be obtained by the Griffith Developmental Assessment Scale.
Gut microbiota
Time Frame: 6 month
Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.
Secondary Outcomes
- Dietary and lifestyle information(3 month)
- Allergic assessment(18 month)
- General demographic materials(14 month)
- Behavior problems(18 month)
- Sleep assessment(18 month)
Investigators
Huilian Zhu
Professor
Sun Yat-sen University