Human Milk Nutrients and Infants' Health Outcomes in South China

The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.

Study Overview

• Status: Recruiting
• Conditions: Healthy

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Huilian Zhu, professor; Phone Number: +86 20 87331811; Email: zhuhl@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Sun Yat-sen University
      • Contact: Huilian Zhu, professor; Phone Number: +86 20 87331811; Email: zhuhl@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children of this study will be recruited from lactating women provided human milk samples before.

Description

Inclusion Criteria:

• age 3-5 years
• healthy children
• breastfeeding at least until 40-45 days of age
• human milk components in mature milk (40-45days) 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The growth of children	The physical growth and body composition of children will be checked by physical examination.	18 month
The cognitive development of children	The brain developments of children will be obtained by the Griffith Developmental Assessment Scale.	18 month
Gut microbiota	Gut microbiota of children will be examined by the analysis of 16S rDNA and metagenomic.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General demographic materials	The general demographic materials of parents and children will be obtained by questionnaire.	14 month
Dietary and lifestyle information	Dietary and lifestyle information of children will be obtained by questionnaire.	3 month
Behavior problems	The behavior problems are collected by Child Behavior Checklist.	18 month
Allergic assessment	Allergic assessments of children will be conducted by questionnaire.	18 month
Sleep assessment	Sleep assessment of infants will be conducted by The Children's Sleep Health Questionnaire.	18 month

Collaborators and Investigators

• Sponsor: Huilian Zhu
• Investigators: Study Chair: Huilian Zhu, professor, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MUAI-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No