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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810210
Recruitment Status : Unknown
Verified August 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : June 22, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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)


Condition or disease Intervention/treatment
Zika Virus Infection on Fetus and Child During the Pregnancy Other: fundus examination Other: Head ultrasound

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 Design
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Study Type : Observational
Estimated Enrollment : 2220 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : June 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Embryofoetopathy incidence within cohort 1 and 3 [ Time Frame: 24 months ]
    incidence comparison between the 2 groups and the calcul of adjusted incidence ratios

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810210


Contacts
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Contact: Bruno Hoen bruno.hoen@chu-guadeloupe.fr

Locations
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France
CH de la Basse Terre Recruiting
Basse-terre Cedex, France, 97109
Contact: Jean-Christophe HEBERT       j.hebert@ch-labasseterre.fr   
CH Andrée Rosemon (CHAR) Active, not recruiting
Cayenne Cedex, France, 97306
CHU de Martinique Recruiting
Fort de France Cedex, France, 97261
Contact: Olivier FLECHELLES       Olivier.flechelles@chu-fortdefrance.fr   
CHU de Pointe à Pitre/Les Abymes Recruiting
Pointe A Pitre, France, 97139
Contact: Aude Abrial       aude.abrial@chu-guadeloupe.fr   
CH LC Fleming Active, not recruiting
Saint Martin Cedex, France, 97054
CH de l'Ouest Guyanais Franck Joly (CHOG) Active, not recruiting
Saint-laurent-du-maroni, France, 97320
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Chair: Bruno Hoen Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Olivier Flechelles CHU de la Martinique
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02810210    
Other Study ID Numbers: C16-19
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Zika
microcephaly
congenital abnormalities
new-born
infant
Additional relevant MeSH terms:
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Infections
Virus Diseases
Zika Virus Infection
Arbovirus Infections
 Vector Borne Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections