Last updated on February 2018

Zika Virus Infection's Neonatal and Pediatric Consequences in French Department of America

Brief description of study

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)

Detailed Study Description

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.

Clinical Study Identifier: NCT02810210

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CHU de Martinique

Fort de France Cedex, France
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Recruitment Status: Open

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