Clinical trial NCT03922594: Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
Official title: Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Microcephaly
Congenital Infection
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Centre Pasteur du Cameroun
name: Guangzhou Women and Children's Medical Center
name: Institut Pasteur of Cote d'Ivoire
name: Pasteur Institute, Ho Chi Minh City
name: Tu Du Hospital
name: Perinatal Society of Sri Lanka
name: University of Colombo
name: University of Lausanne
name: University of Lausanne Hospitals
name: The University of Hong Kong
name: Ministry of Health of Sri Lanka
name: Central Hospital Maternity
name: Essos Hospital Center
name: Guangzhou Baiyun Maternal and Child Health Hospital
name: General Hospital of Yopougon-Attie
name: General Hospital Abobo-Sud
name: Castle Street Hospital for Women
name: De Soyza Hospital for Women
First posted: 2019-04-22
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fetuses or newborns (still-born, medical abortions \[China and Vietnam only\] 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of microcephaly (per 10,000 live births)
timeFrame: At birth
measure: Proportion of microcephaly attributable to ZIKV
timeFrame: At birth
measure: Proportion of microcephaly linked to other infectious etiologies
timeFrame: At birth
Secondary outcomes:
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Central Hospital Maternity
city: Yaoundé
country: Cameroon
facility: Essos Hospital Centre Maternity
city: Guangzhou
country: China
facility: Guangzhou Women's and Children's Hospital
city: Abidjan
country: Côte D'Ivoire
facility: General Hospital Abobo-Sud
city: Abidjan
country: Côte D'Ivoire
facility: General Hospital of Yopougon-Attie
city: Colombo
country: Sri Lanka
facility: Castle Street Hospital for Women
city: Colombo
country: Sri Lanka
facility: De Soyza Hospital for Women
city: Ho Chi Minh City
country: Vietnam
facility: Tu Du Hospital
Study officials:
affiliation: Institut Pasteur
name: Arnaud Fontanet
role: PRINCIPAL_INVESTIGATOR
References: