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Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

G

Guangzhou Women and Children's Medical Center

Status

Completed

Conditions

Microcephaly

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03651687
2016111865-2
81673181 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

47,369 patients

Sex

All

Ages

Under 24 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. With major congenital abnormalities
  2. Multiple births

Trial contacts and locations

1

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Central trial contact

Xiu Qiu, MD,PhD; Wanqing Xiao, Master

Data sourced from clinicaltrials.gov

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