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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 fr

Brief 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 Summary:

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.


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

Current Primary Outcome:

  • Embryofoetopathy incidence within cohort 1 and 3 [ Time Frame: 24 months ]
    incidence comparison between the 2 groups and the calcul of adjusted incidence ratios
  • Comparison of congenital abnormality incidence rates between cohorts 1 and 3 [ Time Frame: 24 months ]
    • Whether or not the mother was symptomatic for ZIKV infection during pregnancy
    • Gestational age at the moment of ZIKV infection
    • The level of ZIKV viremia at the moment of acute ZIKV infection


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Institut National de la Santé Et de la Recherche Médicale, France

Dates:
Date Received: June 20, 2016
Date Started: June 2016
Date Completion: September 2018
Last Updated: August 29, 2016
Last Verified: August 2016