Zika Virus Infection on Fetus and Child During the PregnancyZIKA-DFA-BBNCT02810210

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

An observational study of Zika Virus Infection on Fetus and Child During the Pregnancy, run by Institut National de la Santé Et de la Recherche Médicale, France at 6 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 0 days to 2 years
Conditions the study is for: Zika Virus Infection on Fetus and Child During the Pregnancy
What is being tested?: fundus examination and Head ultrasound
How many people: 1,180 participants
Where: 6 sitesin 4 countries
Study dates: Jun 2016to Jul 2020
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 days to 2 years
All sexes
No healthy volunteers
Child

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)

Who may be able to join

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).
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

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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)
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).

Who cannot join

premature birth (< 35 weeks amenorrhea)
Parents refuse or not able to sign the consent form.
Cohort 2:
premature birth (< 35 weeks amenorrhea)
Parents refuse or not able to sign the consent form.
Cohort 3:
premature birth (< 35 weeks amenorrhea)
Parents refuse or not able to sign the consent form

Trial locations and contacts

6 sites in 4 countries.

Country

City, postcode or hospital

6 sites in 4 countries

French Guiana2 sites

CH Andrée Rosemon (CHAR)
Cayenne
CH de l'Ouest Guyanais Franck Joly (CHOG)
Saint-Laurent-du-Maroni

Other trials in French Guiana

Guadeloupe2 sites

CH de la Basse Terre
Basse-Terre
CHU de Pointe à Pitre/Les Abymes
Pointe-à-Pitre

Other trials in Guadeloupe

France1 site

CH LC Fleming
Saint-Martin, 97054

Other trials in France

Martinique1 site

CHU de Martinique
Fort-de-France

Other trials in Martinique

About this study

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

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)

Read the 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.

Conditions: Zika Virus Infection on Fetus and Child During the Pregnancy
Being tested: fundus examination, Head ultrasound
Keywords: Zika, microcephaly, congenital abnormalities, new-born, infant
Medical subject headings: Zika Virus Infection, Microcephaly, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fundus examinationOther
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 ultrasoundOther
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.

Study groups in NCT02810210
Study group	Role	What they receive
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 Receives: Other: fundus examination; Other: Head ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

Embryofoetopathy incidence within cohort 1 and 3
incidence comparison between the 2 groups and the calcul of adjusted incidence ratios
Measured: 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
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Jul 2020

First posted22 Jun 2016 (estimated)
Study startJun 2016
Primary completionJul 2020
Study completionJul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Zika Virus Infection on Fetus and Child During the PregnancyStudies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02810210
Sponsor's protocol ID: C16-19
Acronym: ZIKA-DFA-BB
Status last verified: Dec 2024
First submitted: 20 Jun 2016
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 33472606