Maternal and Infant Health and Breast Milk Study in South China

Healthy Clinical Trial

Official title:

Maternal and Infant Health and Breast Milk Study in South China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04655820
• Other study ID #: HM-2020
• Status: Active, not recruiting
• Start date: November 20, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
China	SunYat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of nutrients in breast milk samples	The nutrients were detected from breast milk samples of mothers by chemical analysis	14 months
Primary	The level of nutrients in blood samples	The nutrients were detected from blood samples of mothers and infants by chemical analysis	14 months
Secondary	General demographic materials	The general demographic materials of mothers were obtained by questionnaire or medical treatment records	14 months
Secondary	Dietary and lifestyle information	Dietary and lifestyle information of mothers were obtained by Food Frequency Questionnaire and 24-hour meal review questionnaire	14 months
Secondary	Health follow-up	Dietary and health outcome of infants were obtained by questionnaire or medical treatment records	14 months