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CompletedNCT03651687Updated Oct 1, 2024

Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

An observational study in Microcephaly, sponsored by Guangzhou Women and Children's Medical Center. Completed at 1 site in China. Open to participants aged Up to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
47,369
Ages
Up to 24 Months
Sex
All
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Study 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 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.

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Conditions studied

  • Microcephaly

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Keywords

  • Head circumference
  • Neurodevelopment
  • Newborn
  • Infant
  • Surveillance
  • Prediction
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In context

Microcephaly

22 studies on the registry are indexed under Microcephaly; 5 are open to participants now.

This study's enrollment of 47,369 is above the median of 232 across 16 observational studies indexed under Microcephaly.

Browse Microcephaly studies →

Lead sponsor

Guangzhou Women and Children's Medical Center is the lead sponsor of 58 studies on the registry; 30 are open to participants now.

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

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Who can participate

Ages eligible
Up to 24 Months
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Newborns born after 24+0 weeks of gestation
  2. Newborns delivered at the study hospitals

Exclusion criteria

Exclusion Criteria:

  1. With major congenital abnormalities
  2. Multiple births
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
47,369 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Prevalence of microcephaly

    Assessed by the head circumference measured using a standard tool

    Time frame: At birth

Secondary outcomes

  1. Neurodevelopmental performance of children

    Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules or Ages and Stages Questionnaire

    Time frame: At birth, 6 weeks, 6 months, 1 year and 2 years

  2. Head circumference changes of children

    Head circumference changes from birth to infancy (catch-up or drop)

    Time frame: At birth, 6 weeks, 6 months, 1 year to 2 years

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Study locations

1 site
  • Guangzhou Women and Children's Medical Center, China
    Guangzhou, China
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2017 to primary completion in Sep 2024, 91 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2018
First posted
Aug 29, 2018
StartActual
Feb 10, 2017
Primary completionActual
Sep 27, 2024
CompletionActual
Sep 27, 2024
Last update
Oct 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03651687
Lead sponsor
Guangzhou Women and Children's Medical Center
Collaborators
Guangzhou Huadu Women and Children Health Care Hospital, Guangzhou Liwan Women and Children Health Care Hospital, Institut Pasteur
Responsible party
Xiu Qiu (Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center) — Principal investigator
First posted
Aug 29, 2018
Start date
Feb 10, 2017
Primary completion
Sep 27, 2024
Completion
Sep 27, 2024
Last update
Oct 1, 2024

Study contacts

Xiu Qiu, MD,PhD
principal investigator · Guangzhou Women and Children's Medical Center, China

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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