Zika Virus Infection on Fetus and Child During the Pregnancy Clinical Trial
Official title:
Études Observationnelles Des conséquences néonatales et pédiatriques de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016
The Zika epidemic has spread into the three French Overseas Departments in the Caribbean
(DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for
the evaluation of potential complications due to having ZIKV infection during pregnancy.
This study is meant to collect, within usual care practices, clinical and paraclinical
information (including imaging and laboratory results) as well as biological samples
allowing the precise description of the consequences of ZIKV infection during pregnancy.
This study is the 2nd arm of a global research program in the 3 French Overseas Departments
in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the
follow-up of women in the French Overseas Departments who are pregnant during the Zika
epidemic period.
The study population is made up of infants born during and up to 9 months after the end of
the Zika epidemic period in the French Overseas Departments.
The data and biological specimens collected for this project will be done so through the
recommended standard of care which has been put in place considering the ZIKV epidemic in
the 3 French Overseas Departments, upholding existing recommendations (profession and/or
recommendation from the public health authorities)
At birth (from Day 0 to Day 4):
- Standardized clinical examination by a pediatrician
- Capillary blood sample to do ZIKV serology (in the case that no cord-blood sample was
taken at birth) through neonatal heel prick (Guthrie's test)
- Cranial ultrasound
- Screening test for hearing capabilities by auditory evoked potentials
- Fundus of the eye or retinal image capture by RetCam®.
Follow-up from Day 4 to 2 years:
- Clinical examination focusing on neuropsychomotor development at the 2nd, 4th, 9th, 18th
and 24th month.
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Observational Model: Cohort, Time Perspective: Prospective