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

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

Status: Completed

Conditions: Zika Virus Infection on Fetus and Child During the Pregnancy

Treatments: Other: Head ultrasound; Other: fundus examination

Study type: Observational

Funder types: Other

Identifiers

NCT02810210

C16-19

Details and patient eligibility

About

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)

Full 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.

Enrollment: 1,180 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,180 participants in 3 patient groups

Cohort 1

Description:

Monitoring of children born without congenital anomalies to mothers with biologically confirmed ZIKV's infection during the pregnancy

Cohort 2

Description:

Monitoring of children born with congenital anomalies to mothers with biologically confirmed ZIKV's infection during the pregnancy

Cohort 3

Description:

Monitoring of children born without congenital anomalies to mothers with no biologically confirmed ZIKV's infection during the pregnancy

Treatment:

Other: fundus examination

Other: Head ultrasound