Completed

NCT Number: NCT02810210

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

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)

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Key information

Conditions

Zika Virus Infection on Fetus and Child During the Pregnancy Arbovirus Infections Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Flaviviridae Infections Flavivirus Infections Infections Malformations of Cortical Development Malformations of Cortical Development, Group I Microcephaly Mosquito-Borne Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations RNA Virus Infections Vector Borne Diseases Virus Diseases Zika Virus Infection

Age range

0 day–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CH de la Basse Terre, Basse-terre Cedex, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Cohort 1:

Inclusion criteria

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
Mother enrollment in ZIKA DFA FE study (Module 1) OR
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
No birth defects in newborn at birth (see Appendix 5).

Exclusion criteria

premature birth (< 35 weeks amenorrhea)
Parents refuse or not able to sign the consent form.

Cohort 2:

Inclusion criteria

Mother enrollment in ZIKA DFA FE study (Module 2) OR
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

premature birth (< 35 weeks amenorrhea)
Parents refuse or not able to sign the consent form.

Cohort 3:

Inclusion criteria

Mother enrollment in ZIKA DFA FE study (Module 3 &4)
Mother's ZIKV seronegative in childbirth
No birth defects in newborn at birth (see Appendix 5).

Exclusion criteria

premature birth (< 35 weeks amenorrhea)
Parents refuse or not able to sign the consent form

Treatment and study plan

fundus examination

Other

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.

Head ultrasound

Other

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.

Primary outcomes

Embryofoetopathy incidence within cohort 1 and 3

Time frame: 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

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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study 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

Acronym: ZIKA-DFA-BB

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Jun 22, 2016
Registry last updated: Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed