NCT02810210

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,180 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 0 Days – 2 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Zika Virus Infection on Fetus and Child During the Pregnancy

Interventions

Type	Name	Description
OTHER	fundus examination	In cohort 3, a fundus examination will be carried in addition to the current medical practice. This exam is part of current medical practice for other groups.
OTHER	Head ultrasound	In cohort 3, a head ultrasound will be carried in addition to the current medical practice. This exam is part of current medical practice for other groups.

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2016-06-22
• Last updated: 2024-12-09

Locations

6 sites across 1 country: France