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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03668327
Other study ID # 2018090501
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2012
Est. completion date December 31, 2038

Study information

Verified date February 2024
Source Guangzhou Women and Children's Medical Center
Contact Xiu Qiu, MD,PhD
Phone 0086 20 38367160
Email qxiu0161@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 31, 2038
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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


Locations

Country Name City State
China Guangzhou Women and Children's Medical Center, China Guangzhou

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (1)

Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Neurodevelopment at early childhood 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 At age of 1 year
Secondary Intelligence quotient of offspring 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 At age of 6 years old
Secondary Height changes during childhood and adolescence Measured by nurses in clinic using a standard tool At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year
Secondary Weight changes during childhood and adolescence Measured by nurses in clinic using a standard tool At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year
Secondary Change of intestinal flora during early childhood Assessed by analyses of stool samples At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Secondary Changes of body fat percentage during early childhood Assessed by Dual Energy X-Ray Absorptiometry (defined as total mass of fat divided by total body mass) At age of 3 years, 6 years, 12 years and 18 years old
Secondary Changes of bone density during early childhood Assessed by Dual Energy X-Ray Absorptiometry At age of 3 years, 6 years, 12 years and 18 years old
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