Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

NCT03651687 | Completed

• 2 other identifiers: 2016111865-281673181
• Study Type: observational
• Target: 47,369
• Locations: 1 country
• Sites: 1

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.

Conditions

Microcephaly

Keywords

Head circumference; Neurodevelopment; Newborn; Infant; Surveillance; Prediction

Outcome Measures

Primary Outcomes (1)

• Prevalence of microcephaly

  Assessed by the head circumference measured using a standard tool

  At birth

Secondary Outcomes (2)

• Neurodevelopmental performance of children

  At birth, 6 weeks, 6 months, 1 year and 2 years

• Head circumference changes of children

  At birth, 6 weeks, 6 months, 1 year to 2 years

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population are infants born in the maternity hospitals from Guangzhou surveillance system.

You may qualify if:

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

You may not qualify if:

• With major congenital abnormalities
• Multiple births

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead
• Guangzhou Huadu Women and Children Health Care Hospital: collaborator
• Guangzhou Liwan Women and Children Health Care Hospital: collaborator
• Institut Pasteur: collaborator

Study Sites (1)

Guangzhou Women and Children's Medical Center, China

Guangzhou, China

Location

Related Publications (1)

• 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.

  PMID: 28432291 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

At birth: cord, cord blood and placenta; During infancy: oral swab.

MeSH Terms

Conditions

Microcephaly

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiu Qiu, MD,PhD

  Guangzhou Women and Children's Medical Center, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Born in Guangzhou Cohort Study

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 29, 2018
• Study Start: February 10, 2017
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CN (1)