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COMPLETED
NCT02810210

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

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

0 Days - 2 Years

Study Type

OBSERVATIONAL

Enrollment

1180

Start Date

2016-06

Completion Date

2020-07

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

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.

Locations (6)

CH LC Fleming

Saint-Martin, France

CH Andrée Rosemon (CHAR)

Cayenne, French Guiana

CH de l'Ouest Guyanais Franck Joly (CHOG)

Saint-Laurent-du-Maroni, French Guiana

CH de la Basse Terre

Basse-Terre, Guadeloupe

CHU de Pointe à Pitre/Les Abymes

Pointe-à-Pitre, Guadeloupe

CHU de Martinique

Fort-de-France, Martinique