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Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

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ClinicalTrials.gov Identifier: NCT03651687
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Guangzhou Huadu Women and Children Health Care Hospital
Guangzhou Liwan Women and Children Health Care Hospital
Institut Pasteur
Information provided by (Responsible Party):
Xiu Qiu, Guangzhou Women and Children's Medical Center

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 90000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Guangzhou Surveillance and Clinical Study in Microcephaly
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021





Primary Outcome Measures :
  1. Prevalence of microcephaly [ Time Frame: At birth ]
    Assessed by the head circumference measured using a standard tool


Secondary Outcome Measures :
  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)


Biospecimen Retention:   Samples With DNA
At birth: cord, cord blood and placenta; During infancy: oral swab.


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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651687


Contacts
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Contact: Xiu Qiu, MD,PhD 0086 20 38367160 qxiu0161@163.com
Contact: Wanqing Xiao, Master 0086 20 38367159

Locations
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China
Guangzhou Women and Children's Medical Center, China Recruiting
Guangzhou, China
Contact: Xiu Qiu, MD,PhD    0086 20 38367160    qxiu0161@163.com   
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Guangzhou Huadu Women and Children Health Care Hospital
Guangzhou Liwan Women and Children Health Care Hospital
Institut Pasteur
Investigators
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Principal Investigator: Xiu Qiu, MD,PhD Guangzhou Women and Children's Medical Center, China
Publications:
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Responsible Party: Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT03651687    
Other Study ID Numbers: 2016111865-2
81673181 ( Other Grant/Funding Number: National Natural Science Foundation of China )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiu Qiu, Guangzhou Women and Children's Medical Center:
Head circumference
Neurodevelopment
Newborn
Infant
Surveillance
Prediction
Additional relevant MeSH terms:
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Microcephaly
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities