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

Terminated

• Conditions: Microcephaly; Congenital Infection
• Interventions: Diagnostic Test: Differential diagnosis for infectious causes of microcephaly

• Registration Number: NCT03922594
• Lead Sponsor: Institut Pasteur

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-22
• Study Start: 2019-05-20
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cameroon	Differential diagnosis for infectious causes of microcephaly	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
Sri Lanka	Differential diagnosis for infectious causes of microcephaly	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	Differential diagnosis for infectious causes of microcephaly	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	Differential diagnosis for infectious causes of microcephaly	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
Vietnam	Differential diagnosis for infectious causes of microcephaly	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

Primary Outcome Measures

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

Trial Locations

Locations (8)

De Soyza Hospital for Women; 🇱🇰 Colombo, Sri Lanka

Essos Hospital Centre Maternity; 🇨🇲 Yaoundé, Cameroon

General Hospital Abobo-Sud; 🇨🇮 Abidjan, Côte D'Ivoire

Castle Street Hospital for Women; 🇱🇰 Colombo, Sri Lanka

Tu Du Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Guangzhou Women's and Children's Hospital; 🇨🇳 Guangzhou, China

Central Hospital Maternity; 🇨🇲 Yaoundé, Cameroon

General Hospital of Yopougon-Attie; 🇨🇮 Abidjan, Côte D'Ivoire