Zika Virus Infection's Neonatal and Pediatric Consequences in French Department of America (ZIKA-DFA-BB)

August 29, 2016 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Basse-terre Cedex, France, 97109
      • Cayenne Cedex, France, 97306
        • Active, not recruiting
        • CH Andrée Rosemon (CHAR)
      • Fort de France Cedex, France, 97261
      • Pointe A Pitre, France, 97139
      • Saint Martin Cedex, France, 97054
        • Active, not recruiting
        • CH LC Fleming
      • Saint-laurent-du-maroni, France, 97320
        • Active, not recruiting
        • CH de l'Ouest Guyanais Franck Joly (CHOG)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Babies born during and up to 9 months after the end of the epidemic of ZIKV within the french indies and Guyana.

3 groups : babies without any congenital abnormalities from mother with ZIKV infection, biologicaly confirmed during the pregnancy (cohort1); babies with congenital abnormalities at birth (cohort 2); babies without any congenital abnormalities from mother without ZIKV infection during the pregnancy (cohort 3)

Description

Cohort 1:

Inclusion criteria:

  1. symptomatic acute infection ZIKV has been confirmed in mother by RT-PCR in blood or urine or serology neutralization or other specific technique that would be validated and become available before the end of the epidemic period OR
  2. Mother enrollment in ZIKA DFA FE study (Module 1) OR
  3. ZIKA seroconversion documented during pregnancy, especially objectified in the pregnant women's monitoring in the modules 3 and 4 of ZIKA-DFA-FE study AND
  4. No birth defects in newborn at birth (see Appendix 5).

Exclusion criteria:

  1. premature birth (< 35 weeks amenorrhea)
  2. Parents refuse or not able to sign the consent form.

Cohort 2:

Inclusion Criteria:

  1. Mother enrollment in ZIKA DFA FE study (Module 2) OR
  2. Children born from mothers enrolled in ZIKA-DFA-FE study (modules 3 and 4) and having congenital abnormalities discovered at birth

And having at least one of these following abnormalities:

Head circumference (HC) < 2 SD, using Intergrowth curves:

(http://intergrowth21.ndog.ox.ac.uk/Newborn/en/ManualEntry) Presence of birth defects in newborn at birth (see Annex 5)

Exclusion criteria:

  1. premature birth (< 35 weeks amenorrhea)
  2. Parents refuse or not able to sign the consent form.

Cohort 3:

Inclusion Criteria:

  1. Mother enrollment in ZIKA DFA FE study (Module 3 &4)
  2. Mother's ZIKV seronegative in childbirth
  3. No birth defects in newborn at birth (see Appendix 5).

Exclusion criteria:

  1. premature birth (< 35 weeks amenorrhea)
  2. Parents refuse or not able to sign the consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Monitoring of children born without congenital anomalies to mothers with biologically confirmed ZIKV's infection during the pregnancy
Cohort 2
Monitoring of children born with congenital anomalies to mothers with biologically confirmed ZIKV's infection during the pregnancy
Cohort 3
Monitoring of children born without congenital anomalies to mothers with no biologically confirmed ZIKV's infection during the pregnancy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryofoetopathy incidence within cohort 1 and 3
Time Frame: 24 months
incidence comparison between the 2 groups and the calcul of adjusted incidence ratios
24 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Bruno Hoen, Institut National de la Santé Et de la Recherche Médicale, France
  • Principal Investigator: Olivier Flechelles, CHU de la Martinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C16-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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