Preterm BirthPBCSGNCT03668327
Preterm Birth Cohort Study in Guangzhou
An observational study of Preterm Birth and Neurodevelopment, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Neurodevelopment, Immune Development
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population are childrens born before 37 weeks of gestation and their mothers in Guangzhou.
Who may be able to join
- 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
Who cannot join
- Multiple birth
- Stillbirth
- With major congenital abnormalities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yashu Kuang, Master contact
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's Medical Center, China
Guangzhou
Xiu Qiu, MD,PhD, 0086 20 38367160, qxiu0161@163.com
About this study
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.
- Keywords
- Preterm, Cohort, Early development, Child
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At age of 1 year
Secondary outcomes (6)
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
Measured: At age of 6 years old
Height changes during childhood and adolescence
Measured by nurses in clinic using a standard tool
Measured: 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
Measured by nurses in clinic using a standard tool
Measured: 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
Assessed by analyses of stool samples
Measured: 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
Assessed by Dual Energy X-Ray Absorptiometry (defined as total mass of fat divided by total body mass)
Measured: At age of 3 years, 6 years, 12 years and 18 years old
Changes of bone density during early childhood
Assessed by Dual Energy X-Ray Absorptiometry
Measured: At age of 3 years, 6 years, 12 years and 18 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Feb 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiu Qiu, Guangzhou Women and Children's Medical Center
- Investigators
- Xiu Qiu, MD,PhD, Principal investigator, Guangzhou Women and Children's Medical Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668327
- Sponsor's protocol ID
- 2018090501
- Acronym
- PBCSG
- Status last verified
- Feb 2024
- First submitted
- 7 Sep 2018
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Birth Cohort Study in Guangzhou
- ClinicalTrials.gov ID
- NCT03668327
- Acronym / sponsor ID
- PBCSG / 2018090501
- Keywords
- Preterm, Cohort, Early development, Child
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population are childrens born before 37 weeks of gestation and their mothers in Guangzhou.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Multiple birth
- Stillbirth
- With major congenital abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | – |
Primary outcome
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
6 secondary outcomes
Intelligence quotient of offspring
Time frame: At age of 6 years old
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
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
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
Changes of body fat percentage during early childhood
Time frame: At age of 3 years, 6 years, 12 years and 18 years old
Changes of bone density during early childhood
Time frame: At age of 3 years, 6 years, 12 years and 18 years old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 28321694Qiu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yashu Kuang, Master contact
Xiu Qiu, MD,PhD principal investigator
Guangzhou Women and Children's Medical Center, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Neurodevelopment, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiu Qiu, MD,PhD (0086 20 38367160, qxiu0161@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopment at early childhood (time frame: At age of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03668327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.