NCT02943304

Neurodevelopment Outcome of Newborns Exposed to Zika Virus (ZIKV) in Utero

Risk Evaluation of Fetal Nervous System and Neurodevelopment Disorders in Infants of Women Exposed to Zika Virus Infection During Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 284 (actual)
• Sponsor: Universidad Industrial de Santander · Academic / Other
• Sex: Female
• Age: 13 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This prospective cohort study will determine the natural history of fetal exposure to Zika virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according to trimester of infection and as exposed and unexposed to ZIKV.

Detailed description

Infection with Zika Virus (ZIKV) is an emerging disease in South America and a serious public health problem due to a high prevalence of one of the vectors that transmit the virus, Aedes Aegypti, and the severe and sometimes fatal complications that can be generated in the fetus of women infected by the virus during their pregnancy. Retrospective studies have shown an association with microcephaly, cerebral calcifications, dysgenesis of the corpus callosum, and other anomalies of the central nervous system (CNS). The high risk of neurodevelopmental impairment in the exposed newborn is a major concern. The epidemiologic and neurobiological evidence supporting the link between infection of pregnant women, trimester of infection, and the development of such anomalies in the fetus is growing to the extent that the Center for Disease Control has officially made a statement supporting this association. Although the dimension of the public health impact is still unknown, limited prospective data makes counseling of pregnant women difficult, especially when they are considering termination of pregnancy. Given that evidence supporting the neurotropic quality of ZIKV and the potential variations of the effect the virus may have on the developing fetal brain according to the gestational age of infection, we have designed a prospective cohort study to determine whether exposure of the fetus to ZIKV in symptomatic mothers results in fetal CNS anomalies and/or impaired neurodevelopmental outcome of the newborn. As a secondary aim we will determine the effect gestational age has on severity of CNS anomalies and neurodevelopmental outcome.

Conditions

• Microcephaly
• Mental Retardation

Interventions

Type	Name	Description
OTHER	Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-12-15
• Completion: 2022-12-20
• First posted: 2016-10-24
• Last updated: 2023-01-09

Locations

1 site across 1 country: Colombia