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RecruitingNCT03668327PBCSGUpdated Feb 26, 2024

Preterm Birth Cohort Study in Guangzhou

An observational study in Preterm Birth, Neurodevelopment and Immune Development, sponsored by Guangzhou Women and Children's Medical Center. Recruiting at 1 site in China. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Guangzhou Women and Children's Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2012; still recruiting 14 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Browse trials for

Keywords

  • Preterm
  • Cohort
  • Early development
  • Child
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Guangzhou Women and Children's Medical Center is the lead sponsor of 56 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  1. Multiple birth
  2. Stillbirth
  3. With major congenital abnormalities
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At age of 1 year

Secondary outcomes

  1. 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

    Time frame: At age of 6 years old

  2. Height changes during childhood and adolescence

    Measured by nurses in clinic using a standard tool

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

  3. Weight changes during childhood and adolescence

    Measured by nurses in clinic using a standard tool

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

  4. Change of intestinal flora during early childhood

    Assessed by analyses of stool samples

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

  5. 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)

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

  6. Changes of bone density during early childhood

    Assessed by Dual Energy X-Ray Absorptiometry

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

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Study locations

1 of 1 sites recruiting
  • Guangzhou Women and Children's Medical Center, China
    Guangzhou, China
    Recruiting
08

References and documents

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. PubMed 28321694 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03668327
Lead sponsor
Guangzhou Women and Children's Medical Center
Responsible party
Xiu Qiu (Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center) — Principal investigator
First posted
Sep 12, 2018
Start date
Feb 1, 2012
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2038 (estimated)
Last update
Feb 26, 2024

Study contacts

Xiu Qiu, MD,PhD
Contact
qxiu0161@163.com
0086 20 38367160
Yashu Kuang, Master
Contact
0086 20 38367159
Xiu Qiu, MD,PhD
principal investigator · Guangzhou Women and Children's Medical Center, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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