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

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: Completed
• Conditions: Zika Virus Infection on Fetus and Child During the Pregnancy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1180

Contacts and Locations

Study Locations

• France
  • Basse-terre Cedex, France, 97109
    • CH de la Basse Terre
  • Cayenne Cedex, France, 97306
    • CH Andrée Rosemon (CHAR)
  • FORT DE France Cedex, France, 97261
    • CHU de Martinique
  • Pointe A Pitre, France, 97139
    • CHU de Pointe à Pitre/Les Abymes
  • Saint Martin Cedex, France, 97054
    • CH LC Fleming
  • Saint-laurent-du-maroni, France, 97320
    • CH de l'Ouest Guyanais Franck Joly (CHOG)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• 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)

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

How is the study designed?

Number of groups / cohorts

3

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	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	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

• 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

General Publications

• Grant R, Flechelles O, Tressieres B, Dialo M, Elenga N, Mediamolle N, Mallard A, Hebert JC, Lachaume N, Couchy E, Hoen B, Fontanet A. In utero Zika virus exposure and neurodevelopment at 24 months in toddlers normocephalic at birth: a cohort study. BMC Med. 2021 Jan 21;19(1):12. doi: 10.1186/s12916-020-01888-0.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimated): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: infant; Zika; congenital abnormalities; microcephaly; new-born
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; RNA Virus Infections; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Zika Virus Infection; Infections; Virus Diseases
• Other Study ID Numbers: C16-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO