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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,180
- 试验地点
- 6
- 主要终点
- Embryofoetopathy incidence within cohort 1 and 3
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Exclusion criteria:
- •premature birth (< 35 weeks amenorrhea)
- •Parents refuse or not able to sign the consent form.
- •Inclusion Criteria:
- •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).
- •Exclusion criteria:
- •premature birth (< 35 weeks amenorrhea)
- •Parents refuse or not able to sign the consent form
排除标准
- 未提供
结局指标
主要结局
Embryofoetopathy incidence within cohort 1 and 3
时间窗: 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
时间窗: 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
次要结局
未报告次要终点