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Preterm Birth Cohort Study in Guangzhou (PBCSG)

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ClinicalTrials.gov Identifier: NCT03668327
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Xiu Qiu, 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.

Condition or disease
Preterm Birth Neurodevelopment Immune Development Host and Microbiome

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preterm Birth Cohort Study in Guangzhou
Actual Study Start Date : February 1, 2012
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2038



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Intelligence quotient of offspring [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At age of 3 years, 6 years, 12 years and 18 years old ]
    Assessed by Dual Energy X-Ray Absorptiometry


Biospecimen Retention:   Samples With DNA
At delivery: maternal blood, cord, cord blood and placenta. During infancy: dry blood spot, stool and blood. During childhood: blood, buccal swab and stool.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population are childrens born before 37 weeks of gestation and their mothers in Guangzhou.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668327


Contacts
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Contact: Xiu Qiu, MD,PhD 0086 20 38367160 qxiu0161@163.com
Contact: Yashu Kuang, Master 0086 20 38367159

Locations
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China
Guangzhou Women and Children's Medical Center, China Recruiting
Guangzhou, China
Contact: Xiu Qiu, MD,PhD    0086 20 38367160    qxiu0161@163.com   
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Investigators
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Principal Investigator: Xiu Qiu, MD,PhD Guangzhou Women and Children's Medical Center, China
Publications:
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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: September 12, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiu Qiu, Guangzhou Women and Children's Medical Center:
Preterm
Cohort
Early development
Child
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications