Clinical trial NCT02810210: Zika Virus Infection's Neonatal and Pediatric Consequences in French Department of America
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Zika Virus Infection on Fetus and Child During the Pregnancy
Keywords: Zika
microcephaly
congenital abnormalities
new-born
infant
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2016-06-22
Enrollment: 1180
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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 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.

Eligibility 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

Primary outcomes:
measure: Embryofoetopathy incidence within cohort 1 and 3
timeFrame: 24 months
measure: Comparison of congenital abnormality incidence rates between cohorts 1 and 3
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basse-terre Cedex
country: France
facility: CH de la Basse Terre
city: Cayenne Cedex
country: France
facility: CH Andrée Rosemon (CHAR)
city: FORT DE France Cedex
country: France
facility: CHU de Martinique
city: Pointe A Pitre
country: France
facility: CHU de Pointe à Pitre/Les Abymes
city: Saint Martin Cedex
country: France
facility: CH LC Fleming
city: Saint-laurent-du-maroni
country: France
facility: CH de l'Ouest Guyanais Franck Joly (CHOG)
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Bruno Hoen
role: STUDY_CHAIR
affiliation: CHU de la Martinique
name: Olivier Flechelles
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.