MicrocephalyNCT03651687
Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)
An observational study of Microcephaly, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Microcephaly
- How many people
- 47,369 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2017to 27 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population are infants born in the maternity hospitals from Guangzhou surveillance system.
Who may be able to join
- Newborns born after 24+0 weeks of gestation
- Newborns delivered at the study hospitals
Who cannot join
- With major congenital abnormalities
- Multiple births
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Microcephaly
- Keywords
- Head circumference, Neurodevelopment, Newborn, Infant, Surveillance, Prediction
- Medical subject headings
- Microcephaly
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.
Prevalence of microcephaly
Assessed by the head circumference measured using a standard tool
Measured: At birth
Secondary outcomes (2)
Neurodevelopmental performance of children
Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules or Ages and Stages Questionnaire
Measured: At birth, 6 weeks, 6 months, 1 year and 2 years
Head circumference changes of children
Head circumference changes from birth to infancy (catch-up or drop)
Measured: At birth, 6 weeks, 6 months, 1 year to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start10 Feb 2017
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
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 MicrocephalyStudies 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
- 47,369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Huadu Women and Children Health Care Hospital, Guangzhou Liwan Women and Children Health Care Hospital, Institut Pasteur
- 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
- NCT03651687
- Sponsor's protocol ID
- 2016111865-2
- Other IDs
- 81673181
- Status last verified
- Sep 2024
- First submitted
- 22 Aug 2018
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He JR, Li WD, Lu MS, Guo Y, Chan FF, Lu JH, Zhang LF, Shen SY, Xia XY, Wang P, Mo WJ, Lam KBH, Hirst JE, Xia HM, Qiu X. Birth weight changes in a major city under rapid socioeconomic transition in China. Sci Rep. 2017 Apr 21;7(1):1031. doi: 10.1038/s41598-017-01068-w.
PubMed 28432291
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guangzhou Surveillance and Clinical Study in Microcephaly
- ClinicalTrials.gov ID
- NCT03651687
- Acronym / sponsor ID
- 2016111865-2
- Conditions
- Microcephaly
- Keywords
- Head circumference, Neurodevelopment, Newborn, Infant, Surveillance, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47,369 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Collaborators
- Guangzhou Huadu Women and Children Health Care Hospital, Guangzhou Liwan Women and Children Health Care Hospital, Institut Pasteur
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 29 Aug 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population are infants born in the maternity hospitals from Guangzhou surveillance system.
Key inclusion criteria (2 listed)
- Newborns born after 24+0 weeks of gestation
- Newborns delivered at the study hospitals
Key exclusion criteria (2 listed)
- With major congenital abnormalities
- Multiple births
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
Prevalence of microcephaly
Time frame: At birth
Assessed by the head circumference measured using a standard tool
2 secondary outcomes
Neurodevelopmental performance of children
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 28432291He JR, Li WD, Lu MS, Guo Y, Chan FF, Lu JH, Zhang LF, Shen SY, Xia XY, Wang P, Mo WJ, Lam KBH, Hirst JE, Xia HM, Qiu X. Birth weight changes in a major city under rapid socioeconomic transition in China. Sci Rep. 2017 Apr 21;7(1):1031. doi: 10.1038/s41598-017-01068-w.
- 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. This study is not recruiting at the moment.
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 Microcephaly, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of microcephaly (time frame: At birth). 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 NCT03651687, 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 1 Oct 2024.