PBCSG: Preterm Birth Cohort Study in Guangzhou

Sponsor
Guangzhou Women and Children's Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03668327
Collaborator
(none)
5,000
1
323
15.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Preterm Birth Cohort Study in Guangzhou
    Actual Study Start Date :
    Feb 1, 2012
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2038

    Outcome Measures

    Primary Outcome Measures

    1. Neurodevelopment at early childhood [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 Outcome Measures

    1. Intelligence quotient of offspring [At 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

    2. 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]

      Measured by nurses in clinic using a standard tool

    3. 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]

      Measured by nurses in clinic using a standard tool

    4. 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]

      Assessed by analyses of stool samples

    5. Changes of body fat percentage during early childhood [At 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)

    6. Changes of bone density during early childhood [At age of 3 years, 6 years, 12 years and 18 years old]

      Assessed by Dual Energy X-Ray Absorptiometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Women and Children's Medical Center, China Guangzhou China

    Sponsors and Collaborators

    • Guangzhou Women and Children's Medical Center

    Investigators

    • Principal Investigator: Xiu Qiu, MD,PhD, Guangzhou Women and Children's Medical Center, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center
    ClinicalTrials.gov Identifier:
    NCT03668327
    Other Study ID Numbers:
    • 2018090501
    First Posted:
    Sep 12, 2018
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 22, 2022