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Preterm Birth Cohort Study in Guangzhou

Recruiting
Conditions
Immune Development
Preterm Birth
Host and Microbiome
Neurodevelopment
Registration Number
NCT03668327
Lead Sponsor
Guangzhou Women and Children's Medical Center
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
5000
Inclusion Criteria
  1. Born before 37 weeks of gestation
  2. Born in Guangzhou Women and Children's Medical Center
  3. Intended to remain in Guangzhou for more than 3 years
Exclusion Criteria
  1. Multiple birth
  2. Stillbirth
  3. With major congenital abnormalities

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Neurodevelopment at early childhoodAt 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 Outcome Measures
NameTimeMethod
Changes of bone density during early childhoodAt age of 3 years, 6 years, 12 years and 18 years old

Assessed by Dual Energy X-Ray Absorptiometry

Weight changes during childhood and adolescenceAt birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year

Measured by nurses in clinic using a standard tool

Intelligence quotient of offspringAt age of 6 years old

Assessed by using Wechsler's Intelligence Scale for Children (WISC), which can generate a full scale intelligence quotient score and five primary index scores including verbal comprehension, visual spatial, fluid reasoning, working memory, and processing speed. Intelligence quotient ranges from 40 to 160,in which less than 70 is defined as mental retardation

Height changes during childhood and adolescenceAt birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year

Measured by nurses in clinic using a standard tool

Changes of body fat percentage during early childhoodAt age of 3 years, 6 years, 12 years and 18 years old

Assessed by Dual Energy X-Ray Absorptiometry (defined as total mass of fat divided by total body mass)

Change of intestinal flora during early childhoodAt age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old

Assessed by analyses of stool samples

Trial Locations

Locations (1)

Guangzhou Women and Children's Medical Center, China

🇨🇳

Guangzhou, China

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