Clinical trial NCT03651687: Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)
Official title: Guangzhou Surveillance and Clinical Study in Microcephaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microcephaly
Keywords: Head circumference
Neurodevelopment
Newborn
Infant
Surveillance
Prediction
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Guangzhou Huadu Women and Children Health Care Hospital
name: Guangzhou Liwan Women and Children Health Care Hospital
name: Institut Pasteur
First posted: 2018-08-29
Enrollment: 47369
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are infants born in the maternity hospitals from Guangzhou surveillance system.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of microcephaly
timeFrame: At birth
Secondary outcomes:
measure: Neurodevelopmental performance of children
timeFrame: At birth, 6 weeks, 6 months, 1 year and 2 years
measure: Head circumference changes of children
timeFrame: At birth, 6 weeks, 6 months, 1 year to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center, China
Study officials:
affiliation: Guangzhou Women and Children's Medical Center, China
name: Xiu Qiu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.