Zika Virus Infection's Neonatal and Pediatric Consequences in French Department of America

Completed

• Conditions: Zika Virus Infection on Fetus and Child During the Pregnancy
• Interventions: Other: fundus examination; Other: Head ultrasound

• Registration Number: NCT02810210
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-22
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1180

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 3	Head ultrasound	Monitoring of children born without congenital anomalies to mothers with no biologically confirmed ZIKV's infection during the pregnancy
Cohort 3	fundus examination	Monitoring of children born without congenital anomalies to mothers with no biologically confirmed ZIKV's infection during the pregnancy

Primary Outcome Measures

Name	Time	Method
Embryofoetopathy incidence within cohort 1 and 3	24 months	incidence comparison between the 2 groups and the calcul of adjusted incidence ratios
Comparison of congenital abnormality incidence rates between cohorts 1 and 3	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

Trial Locations

Locations (6)

CH de la Basse Terre; 🇫🇷 Basse-terre Cedex, France

CH Andrée Rosemon (CHAR); 🇫🇷 Cayenne Cedex, France

CHU de Martinique; 🇫🇷 FORT DE France Cedex, France

CHU de Pointe à Pitre/Les Abymes; 🇫🇷 Pointe A Pitre, France

CH LC Fleming; 🇫🇷 Saint Martin Cedex, France

CH de l'Ouest Guyanais Franck Joly (CHOG); 🇫🇷 Saint-laurent-du-maroni, France