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NCT Number: NCT03668327

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.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women and Children's Medical Center, China

Guangzhou, China

Location status: Recruiting

Location contact

Xiu Qiu, MD,PhD

CONTACT

[email protected]

0086 20 38367160

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Multiple birth
  • Stillbirth
  • With major congenital abnormalities

Treatment and study plan

Primary outcomes

  1. Neurodevelopment at early childhood

    Time frame: 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

Secondary outcomes

  1. Intelligence quotient of offspring

    Time frame: At age of 6 years old

    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

  2. Height changes during childhood and adolescence

    Time frame: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year

    Measured by nurses in clinic using a standard tool

  3. Weight changes during childhood and adolescence

    Time frame: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 year

    Measured by nurses in clinic using a standard tool

  4. Change of intestinal flora during early childhood

    Time frame: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old

    Assessed by analyses of stool samples

  5. Changes of body fat percentage during early childhood

    Time frame: At age of 3 years, 6 years, 12 years and 18 years old

    Assessed by Dual Energy X-Ray Absorptiometry (defined as total mass of fat divided by total body mass)

  6. Changes of bone density during early childhood

    Time frame: At age of 3 years, 6 years, 12 years and 18 years old

    Assessed by Dual Energy X-Ray Absorptiometry

Study contacts

Contact information is provided by the study sponsor or research team.

Xiu Qiu, MD,PhD

CONTACT

[email protected]

0086 20 38367160

Yashu Kuang, Master

CONTACT

0086 20 38367159

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Acronym: PBCSG

Important dates

Study start
2012
Primary completion
2025
Study completion
2038
First posted
Sep 12, 2018
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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