Preterm Birth Cohort Study in Guangzhou

Preterm Birth Clinical Trial

— PBCSG  

Official title:

Preterm Birth Cohort Study in Guangzhou

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03668327
• Other study ID #: 2018090501
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Host and Microbiome
• Immune Development
• Neurodevelopment
• Premature Birth
• Preterm Birth

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