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Human Milk Nutrients and Infants' Health Outcomes in South China

Human Milk Nutrients and Infants' Health Outcomes in South China

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05432180
Enrollment
80
Registered
2022-06-27
Start date
2022-06-06
Completion date
2023-12-30
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

None listed

Sponsors

Huilian Zhu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 5 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The growth of children18 monthThe physical growth and body composition of children will be checked by physical examination.
The cognitive development of children18 monthThe brain developments of children will be obtained by the Griffith Developmental Assessment Scale.
Gut microbiota6 monthGut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.

Secondary

MeasureTime frameDescription
Allergic assessment18 monthAllergic assessments of children will be conducted by questionnaire.
General demographic materials14 monthThe general demographic materials of parents and children will be obtained by questionnaire.
Sleep assessment18 monthSleep assessment of infants will be conducted by The Children's Sleep Health Questionnaire.
Dietary and lifestyle information3 monthDietary and lifestyle information of children will be obtained by questionnaire.
Behavior problems18 monthThe behavior problems are collected by Child Behavior Checklist.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026