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

NCT ID: NCT02810210

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-07-31

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.

Conditions

Zika Virus Infection on Fetus and Child During the Pregnancy

Keywords

Zika; microcephaly; congenital abnormalities; new-born; infant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

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

No interventions assigned to this group

Cohort 2

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

No interventions assigned to this group

Cohort 3

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

fundus examination

Intervention Type: 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

Intervention Type: 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.

Interventions

fundus examination

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.

Intervention Type: OTHER

Head ultrasound

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.

Intervention Type: OTHER

Eligibility Criteria

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).

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)

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.

Cohort 2:

1. premature birth (< 35 weeks amenorrhea)

2. Parents refuse or not able to sign the consent form.

Cohort 3:

1. premature birth (< 35 weeks amenorrhea)

2. Parents refuse or not able to sign the consent form

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Hoen

Role: STUDY_CHAIR

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

Olivier Flechelles

Role: PRINCIPAL_INVESTIGATOR

CHU de la Martinique

Locations

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 à Pitre, , France

CH de l'Ouest Guyanais Franck Joly (CHOG)

Saint-laurent-du-maroni, , France

CH LC Fleming

Saint-Martin, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 33472606 (View on PubMed)

Other Identifiers

C16-19

Identifier Type: -

Identifier Source: org_study_id