Zika Virus Infection on Fetus and Child During the Pregnancy Clinical Trial
— ZIKA-DFA-BBOfficial 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.
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)
| Status | Recruiting |
| Enrollment | 2220 |
| Est. completion date | September 2018 |
| Est. primary completion date | September 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 2 Years |
| Eligibility |
Cohort 1: 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). Exclusion criteria: 1. premature birth (< 35 weeks amenorrhea) 2. Parents refuse or not able to sign the consent form. Cohort 2: Inclusion Criteria: 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) Exclusion criteria: 1. premature birth (< 35 weeks amenorrhea) 2. Parents refuse or not able to sign the consent form. Cohort 3: Inclusion Criteria: 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | 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 A Pitre | |
| France | CH LC Fleming | Saint Martin Cedex | |
| France | CH de l'Ouest Guyanais Franck Joly (CHOG) | Saint-laurent-du-maroni |
| Lead Sponsor | Collaborator |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Embryofoetopathy incidence within cohort 1 and 3 | incidence comparison between the 2 groups and the calcul of adjusted incidence ratios | 24 months | No |
| Primary | 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 | No |