Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)
September 27, 2024 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center
Guangzhou Surveillance and Clinical Study in Microcephaly
Screening for microcephaly is important at birth and during early childhood.
The Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM) aims to establish a multicentric surveillance system for microcephaly in newborns and infants, to develop a new head circumference reference and microcephaly criteria basing on the local population in Guangzhou, to improve the prediction model of microcephaly, and to follow up the outcomes of the children diagnosed with microcephaly.
Study Overview
Detailed Description
Microcephaly is associated with neurological dysfunctions in infants and children.
There is not a uniform diagnostic criteria for microcephaly.
The World Health Organization (WHO) recommended a criteria of head circumference (HC) less than 2 standard deviations (SD) below the mean of the Intergrowth-21 standard, which was found not applicable to the newborns and infants in Guangzhou.In the GSCSM, the HC measures of newborns are conducted by trained midwives using a standard tool, and extensive information including adverse perinatal outcomes are collected.
Longitudinal follow up of infants' neurodevelopment in cognitive, motor, emotional and other domains are also to be conducted.
The GSCSM intends to find out the infants who are 'real microcephaly' and most at risk of short-term or long-term adverse outcomes in Guangzhou.
Study Type
Observational
Enrollment (Actual)
47369
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangzhou, China
- Guangzhou Women and Children's Medical Center, China
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study population are infants born in the maternity hospitals from Guangzhou surveillance system.
Description
Inclusion Criteria:
- Newborns born after 24+0 weeks of gestation
- Newborns delivered at the study hospitals
Exclusion Criteria:
- With major congenital abnormalities
- Multiple births
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of microcephaly
Time Frame: At birth
|
Assessed by the head circumference measured using a standard tool
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At birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurodevelopmental performance of children
Time Frame: At birth, 6 weeks, 6 months, 1 year and 2 years
|
Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules or Ages and Stages Questionnaire
|
At birth, 6 weeks, 6 months, 1 year and 2 years
|
|
Head circumference changes of children
Time Frame: At birth, 6 weeks, 6 months, 1 year to 2 years
|
Head circumference changes from birth to infancy (catch-up or drop)
|
At birth, 6 weeks, 6 months, 1 year to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Xiu Qiu, MD,PhD, Guangzhou Women and Children's Medical Center, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2017
Primary Completion (Actual)
September 27, 2024
Study Completion (Actual)
September 27, 2024
Study Registration Dates
First Submitted
August 22, 2018
First Submitted That Met QC Criteria
August 27, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
October 1, 2024
Last Update Submitted That Met QC Criteria
September 27, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016111865-2
- 81673181 (Other Grant/Funding Number: National Natural Science Foundation of China)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.