Congenital Infection, Microcephaly
Conditions
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.
Interventions
DIAGNOSTIC_TESTDifferential diagnosis for infectious causes of microcephaly
Zika virus, cytomegalovirus, rubella, toxoplasmosis
Sponsors
Institut Pasteur
Centre Pasteur du Cameroun
Guangzhou Women and Children's Medical Center
Institut Pasteur of Cote d'Ivoire
Pasteur Institute, Ho Chi Minh City
Tu Du Hospital
Perinatal Society of Sri Lanka
University of Colombo
University of Lausanne
University of Lausanne Hospitals
The University of Hong Kong
Ministry of Health of Sri Lanka
Central Hospital Maternity
Essos Hospital Center
Guangzhou Baiyun Maternal and Child Health Hospital
General Hospital of Yopougon-Attie
General Hospital Abobo-Sud
Castle Street Hospital for Women
De Soyza Hospital for Women
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 2 Days
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Proportion of microcephaly linked to other infectious etiologies | At birth | Proportion of microcephaly linked to other infectious etiologies (non-ZIKV) |
Countries
Cameroon, China, Côte d’Ivoire, Sri Lanka, Vietnam
Outcome results
None listed