NCT03668327

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
154mo left

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2012Dec 2038

Study Start

First participant enrolled

February 1, 2012

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2038

Expected
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

13.9 years

First QC Date

September 7, 2018

Last Update Submit

February 22, 2024

Conditions

Keywords

PretermCohortEarly developmentChild

Outcome Measures

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

    At age of 1 year

Secondary Outcomes (6)

  • 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

  • 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

  • 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 body fat percentage during early childhood

    At age of 3 years, 6 years, 12 years and 18 years old

  • +1 more secondary outcomes

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population are childrens born before 37 weeks of gestation and their mothers in Guangzhou.

You may qualify if:

  • 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

You may not qualify if:

  • Multiple birth
  • Stillbirth
  • With major congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center, China

Guangzhou, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28321694BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

At delivery: maternal blood, cord, cord blood and placenta. During infancy: dry blood spot, stool and blood. During childhood: blood, buccal swab and stool.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Xiu Qiu, MD,PhD

    Guangzhou Women and Children's Medical Center, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiu Qiu, MD,PhD

CONTACT

Yashu Kuang, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Born in Guangzhou Cohort Study

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 12, 2018

Study Start

February 1, 2012

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2038

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations