NCT03922594

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 0 Days – 2 Days
• Healthy volunteers: —

Summary

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.

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.

Conditions

• Microcephaly
• Congenital Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Differential diagnosis for infectious causes of microcephaly	Zika virus, cytomegalovirus, rubella, toxoplasmosis

Timeline

• Start date: 2019-05-20
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2019-04-22
• Last updated: 2022-05-20

Locations

8 sites across 5 countries: Cameroon, China, Côte d’Ivoire, Sri Lanka, Vietnam