Maternal and Infant Health and Breast Milk Study in South China

Completed

• Conditions: Healthy

• Registration Number: NCT04655820
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this study was to investigate the nutrients in breast milk of Chinese mothers and its related factors, as well as exploring the early development of infants.

Detailed Description

Breast milk contains a variety of nutrients that are beneficial to the early development of infants, such as lipids, Vitamins and so on. At present, the level of these nutrients in milk and infant formula are lower and which are present in a different form from that in breast milk. Therefore, this study was designed to investigate the level of nutrients in breast milk of Chinese mothers and learn about its related factors, as well as exploring the relationships between these nutrients and the early development of infants.

Study Timeline

• Study Start: 2018-11-20
• Primary Completion: 2019-12-30
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-07
• Study Completion: 2022-12-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• age 20-45 years
• natural delivery, singleton pregnancy
• healthy term infants（at 37-42 weeks of pregnancy）
• don't smoke and drink
• self-evaluation as physical health
• breastfeeding at least until three months of age
• Apgar score > 8
• sign informed consent

Exclusion Criteria

• suffering from mastitis
• gestational diabetes, hypertension and other metabolic diseases
• AIDS, tuberculosis and other acute or chronic infectious diseases
• severe heart and kidney diseases
• mental system diseases
• cancer and other malignant consumptive disease
• take drugs that affect nutrient metabolism
• infants with congenital and genetic diseases
• with lactation contraindications
• don't agree to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of nutrients in breast milk samples	14 months	The nutrients were detected from breast milk samples of mothers by chemical analysis
The level of nutrients in blood samples	14 months	The nutrients were detected from blood samples of mothers and infants by chemical analysis

Secondary Outcome Measures

Name	Time	Method
Health follow-up	14 months	Dietary and health outcome of infants were obtained by questionnaire or medical treatment records
General demographic materials	14 months	The general demographic materials of mothers were obtained by questionnaire or medical treatment records
Dietary and lifestyle information	14 months	Dietary and lifestyle information of mothers were obtained by Food Frequency Questionnaire and 24-hour meal review questionnaire

Trial Locations

Locations (1)

SunYat-sen University; 🇨🇳 Guangzhou, Guangdong, China