Preterm Birth Clinical Trial
— PBCSGOfficial title:
Preterm Birth Cohort Study in Guangzhou
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Guangzhou Women and Children's Medical Center, China | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
Guangzhou Women and Children's Medical Center |
China,
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
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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