Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

Guangzhou Surveillance and Clinical Study in Microcephaly

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.

Study Overview

• Status: Recruiting
• Conditions: Microcephaly
• Intervention / Treatment: Other

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.

• Study Type: Observational
• Enrollment (Estimated): 90000

Contacts and Locations

• Study Contact: Name: Wanqing Xiao, Master; Phone Number: 0086 20 38367159
• Study Contact Backup: Name: Xiu Qiu, MD,PhD; Phone Number: 0086 20 38367160; Email: qxiu0161@163.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Guangzhou Women and Children's Medical Center, China
    • Contact: Xiu Qiu, MD,PhD; Phone Number: 0086 20 38367160; Email: qxiu0161@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (Child)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurodevelopmental performance of children	Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules or Ages and Stages Questionnaire	At birth, 6 weeks, 6 months, 1 year and 2 years
Head circumference changes of children	Head circumference changes from birth to infancy (catch-up or drop)	At birth, 6 weeks, 6 months, 1 year to 2 years

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center
• Collaborators: Institut Pasteur; Guangzhou Huadu Women and Children Health Care Hospital; Guangzhou Liwan Women and Children Health Care Hospital
• Investigators: Principal Investigator: Xiu Qiu, MD,PhD, Guangzhou Women and Children's Medical Center, China

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Infant; Newborn; Surveillance; Neurodevelopment; Prediction; Head circumference
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Microcephaly
• Other Study ID Numbers: 2016111865-2; 81673181 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No