Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia

Overview

This study will explore whether ZIKV is currently responsible for neurological complications, and particularly microcephaly, in Aedes-infested regions of Sub-Saharan Africa (SSA) and Asia. This will inform regional public health strategies, such as vaccination of women of child-bearing age. It will also demonstrate the public health impact of ZIKV infection and increase the understanding of other regional infectious (e.g. cytomegalovirus) causes of microcephaly.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2021

Detailed Description

This study will last for 2 years, and will include only new cases of microcephaly. Surveillance will take place in large maternities in urban areas (standard procedure) – In each city, ~3000 live births per month will be monitored, so that on average one microcephaly will be diagnosed per month per city (i.e., 24 per city in 2 years) – Microcephaly is defined as less than -3 standard deviation (SD), according to the INTERGROWTH standards by age and sex with abnormal ultrasound and/or clinical examination. Data collection (study activity) – A questionnaire with demographic, exposure and pregnancy details for all mothers Clinical exam and laboratory testing (standard procedure and study activity) – Various biological samples (e.g. blood, placenta) will be collected from mothers and newborns/fetuses and tested for presence of ZIKV, and for other infectious (e.g. rubella, cytomegalovirus) causes of microcephaly – Physical, neurological, hearing and visual examinations for all live births will be performed where possible. Analysis and reporting (study activity) o All results will be shared publically through conferences and peer-reviewed publications.

Interventions

  • Diagnostic Test: Differential diagnosis for infectious causes of microcephaly
    • Zika virus, cytomegalovirus, rubella, toxoplasmosis

Arms, Groups and Cohorts

  • Cameroon
    • Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
  • China
    • Fetuses or newborns (still-born, medical abortions or alive) with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
  • Ivory Coast
    • Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex and severely disproportionate length or weight according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
  • Sri Lanka
    • Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns
  • Vietnam
    • Fetuses or newborns (still-born, medical abortions or alive) with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of microcephaly (per 10,000 live births)
    • Time Frame: At birth
    • Incidence of microcephaly (per 10,000 live births)
  • Proportion of microcephaly attributable to ZIKV
    • Time Frame: At birth
    • Proportion of microcephaly attributable to Zika virus infection
  • Proportion of microcephaly linked to other infectious etiologies
    • Time Frame: At birth
    • Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)

Participating in This Clinical Trial

Inclusion Criteria

  • All infants or fetuses with microcephaly, (defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex, detected during the mother's pregnancy, or at the end of the mother's pregnancy at one of the participating maternities) – and with abnormal ultrasound and/or clinical examination findings for newborns. Exclusion Criteria:

  • Infants/fetuses with microcephaly whose mothers are under the age of 18 years, – or inability or refusal of mothers/ guardians to give informed consent.

Gender Eligibility: All

Minimum Age: 0 Days

Maximum Age: 2 Days

Investigator Details

  • Lead Sponsor
    • Institut Pasteur
  • Collaborator
    • Centre Pasteur du Cameroun
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arnaud Fontanet, Principal Investigator, Institut Pasteur

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