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Completed

NCT Number: NCT03651687

Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

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.

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Key information

Conditions

Microcephaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Malformations of Cortical Development Malformations of Cortical Development, Group I Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women and Children's Medical Center, China

Guangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborns born after 24+0 weeks of gestation
  • Newborns delivered at the study hospitals

Exclusion criteria

  • With major congenital abnormalities
  • Multiple births

Treatment and study plan

Primary outcomes

  1. Prevalence of microcephaly

    Time frame: At birth

    Assessed by the head circumference measured using a standard tool

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Collaborators

  • Guangzhou Huadu Women and Children Health Care Hospital
  • Guangzhou Liwan Women and Children Health Care Hospital
  • Institut Pasteur

Registry information

Official study title

Guangzhou Surveillance and Clinical Study in Microcephaly

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2018
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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