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临床试验/NCT03668327
NCT03668327
招募中
不适用

Preterm Birth Cohort Study in Guangzhou

Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 5,000 人2012年2月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Preterm Birth
发起方
Guangzhou Women and Children's Medical Center
入组人数
5000
试验地点
1
主要终点
Neurodevelopment at early childhood
状态
招募中
最后更新
2年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2012年2月1日
结束日期
2038年12月31日
最后更新
2年前
研究类型
Observational
性别
All

研究者

发起方
Guangzhou Women and Children's Medical Center
责任方
Principal Investigator
主要研究者

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center

入排标准

入选标准

  • Born before 37 weeks of gestation
  • Born in Guangzhou Women and Children's Medical Center
  • Intended to remain in Guangzhou for more than 3 years

排除标准

  • Multiple birth
  • With major congenital abnormalities

结局指标

主要结局

Neurodevelopment at early childhood

时间窗: 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

次要结局

  • Weight changes during childhood and adolescence(At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year)
  • Intelligence quotient of offspring(At age of 6 years old)
  • Height changes during childhood and adolescence(At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year)
  • Changes of body fat percentage during early childhood(At age of 3 years, 6 years, 12 years and 18 years old)
  • Change of intestinal flora during early childhood(At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old)
  • Changes of bone density during early childhood(At age of 3 years, 6 years, 12 years and 18 years old)

研究点 (1)

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