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

NCT02810210 | Completed

• 1 other identifier: C16-19
• Study Type: observational
• Target: 1,180
• Locations: 1 country
• Sites: 6

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)

Conditions

Zika Virus Infection on Fetus and Child During the Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Embryofoetopathy incidence within cohort 1 and 3

  incidence comparison between the 2 groups and the calcul of adjusted incidence ratios

  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

  24 months

Study Arms (3)

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

Other: fundus examination; Other: Head ultrasound

Interventions

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.

Cohort 3

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.

Cohort 3

Eligibility Criteria

• Age: 0 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (6)

CH de la Basse Terre

Basse-terre Cedex, 97109, France

Location

CH Andrée Rosemon (CHAR)

Cayenne Cedex, 97306, France

Location

CHU de Martinique

FORT de France Cedex, 97261, France

Location

CHU de Pointe à Pitre/Les Abymes

Pointe à Pitre, 97139, France

Location

CH de l'Ouest Guyanais Franck Joly (CHOG)

Saint-laurent-du-maroni, 97320, France

Location

CH LC Fleming

Saint-Martin, 97054, France

Location

Related Publications (1)

• 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.

  PMID: 33472606 RESULT

MeSH Terms

Conditions

Zika Virus Infection; Microcephaly; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Bruno Hoen

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

  STUDY CHAIR

• Olivier Flechelles

  CHU de la Martinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)