Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

Guangzhou Surveillance and Clinical Study in Microcephaly

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03651687

Enrollment

47369

Registered

2018-08-29

Start date

2017-02-10

Completion date

2024-09-27

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcephaly

Keywords

Head circumference, Neurodevelopment, Newborn, Infant, Surveillance, Prediction

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of microcephaly	At birth	Assessed by the head circumference measured using a standard tool

Secondary

Measure	Time frame	Description
Neurodevelopmental performance of children	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
Head circumference changes of children	At birth, 6 weeks, 6 months, 1 year to 2 years	Head circumference changes from birth to infancy (catch-up or drop)

Countries

China

Outcome results