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Clinical Trials/NCT04655820
NCT04655820
Completed
Not Applicable

Maternal and Infant Health and Breast Milk Study in South China

Sun Yat-sen University1 site in 1 country400 target enrollmentNovember 20, 2018
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Sun Yat-sen University
Enrollment
400
Locations
1
Primary Endpoint
The level of nutrients in blood samples
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2018
End Date
December 30, 2022
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Huilian Zhu

Professor

Sun Yat-sen University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The level of nutrients in blood samples

Time Frame: 14 months

The nutrients were detected from blood samples of mothers and infants by chemical analysis

The level of nutrients in breast milk samples

Time Frame: 14 months

The nutrients were detected from breast milk samples of mothers by chemical analysis

Secondary Outcomes

  • General demographic materials(14 months)
  • Dietary and lifestyle information(14 months)
  • Health follow-up(14 months)

Study Sites (1)

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