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.
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
- Are there results?
- None posted in the registry
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
Show all 12Show fewer
- 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.
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
Guadeloupe2 sites
CH de la Basse Terre
Basse-Terre
CHU de Pointe à Pitre/Les Abymes
Pointe-à-Pitre
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
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.
Read more
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.
- 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 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.
- 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)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bruno Hoen, Study chair, Institut National de la Santé Et de la Recherche Médicale, FranceOlivier Flechelles, Principal investigator, CHU de la Martinique
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02810210
- Acronym / sponsor ID
- ZIKA-DFA-BB / C16-19
- Keywords
- Zika, microcephaly, congenital abnormalities, new-born, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: fundus examination, Other: Head ultrasoundMonitoring of children born without congenital anomalies to mothers with no biologically confirmed ZIKV's infection during the pregnancy |
Who may qualify
- Ages
- 0 days to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- premature birth (< 35 weeks amenorrhea)
- Parents refuse or not able to sign the consent form.
- premature birth (< 35 weeks amenorrhea)
- Parents refuse or not able to sign the consent form.
- premature birth (< 35 weeks amenorrhea)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fundus examinationIn 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. | Other | Cohort 3 |
| Head ultrasoundIn 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. | Other | Cohort 3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Results publication: PubMed 33472606Grant 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Hoen study chair
Institut National de la Santé Et de la Recherche Médicale, France
Olivier Flechelles principal investigator
CHU de la Martinique
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in French Guiana, Guadeloupe, France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryofoetopathy incidence within cohort 1 and 3 (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.