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Clinical Trials/NCT03668327
NCT03668327
Recruiting
Not Applicable

Preterm Birth Cohort Study in Guangzhou

Guangzhou Women and Children's Medical Center1 site in 1 country5,000 target enrollmentFebruary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Guangzhou Women and Children's Medical Center
Enrollment
5000
Locations
1
Primary Endpoint
Neurodevelopment at early childhood
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The Preterm Birth Cohort Study in Guangzhou (PBCSG) aims to explore the impact of genetic and environmental factors including life styles on preterm birth, to examine the interaction effect between these factors, and to follow up the short-term and long-term outcomes of preterm childrens.

Detailed Description

Preterm birth has become the leading cause of neonatal death and the second leading cause of death among children under five years of age. Preterm childrens are more susceptible to adverse health problems including brain injury and neurodevelopment delay, and are at risk of chronic diseases which could impair the health status and life quality later in life. However, the causes of preterm birth is still not clear, and there are no effective prediction and preventive strategies. The Preterm Birth Cohort Study in Guangzhou (PBCSG) will collect the epidemiological,clinical information and biological specimens including maternal blood,cord blood, placenta, children's blood and stool samples of preterm childrens and their mothers. More importantly, childrens' health status, physical and neurodevelopment will be followed up to late childhood and adolescence. The preterm birth cohort would help to explore the mechanism of preterm birth and to examine the short- and long-term influence of preterm birth on physical health and neurodevelopment of childrens.

Registry
clinicaltrials.gov
Start Date
February 1, 2012
End Date
December 31, 2038
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guangzhou Women and Children's Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center

Eligibility Criteria

Inclusion Criteria

  • Born before 37 weeks of gestation
  • Born in Guangzhou Women and Children's Medical Center
  • Intended to remain in Guangzhou for more than 3 years

Exclusion Criteria

  • Multiple birth
  • With major congenital abnormalities

Outcomes

Primary Outcomes

Neurodevelopment at early childhood

Time Frame: At age of 1 year

Assessed by using the Gesell Developmental Schedules, which include adaptive, gross motor, fine motor, language, and social function domains. Higher score in each domain is considered a better outcome, while no more than 85 is defined as suspected development retardation

Secondary Outcomes

  • Weight changes during childhood and adolescence(At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year)
  • Intelligence quotient of offspring(At age of 6 years old)
  • Height changes during childhood and adolescence(At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year)
  • Changes of body fat percentage during early childhood(At age of 3 years, 6 years, 12 years and 18 years old)
  • Change of intestinal flora during early childhood(At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old)
  • Changes of bone density during early childhood(At age of 3 years, 6 years, 12 years and 18 years old)

Study Sites (1)

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