Preterm Birth Cohort Study in Guangzhou (PBCSG)

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Neurodevelopment; Immune Development; Host and Microbiome
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Yashu Kuang, Master; Phone Number: 0086 20 38367159
• Study Contact Backup: Name: Xiu Qiu, MD,PhD; Phone Number: 0086 20 38367160; Email: qxiu0161@163.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Guangzhou Women and Children's Medical Center, China
    • Contact: Xiu Qiu, MD,PhD; Phone Number: 0086 20 38367160; Email: qxiu0161@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2038

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Child; Cohort; Preterm; Early development
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 2018090501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No