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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02943304
Recruitment Status : Unknown
Verified January 2019 by Mario Augusto Rojas, Universidad Industrial de Santander.
Recruitment status was:  Recruiting
First Posted : October 24, 2016
Last Update Posted : January 17, 2019
University of North Carolina, Chapel Hill
Michigan State University
Information provided by (Responsible Party):
Mario Augusto Rojas, Universidad Industrial de Santander

Brief 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.

Condition or disease Intervention/treatment
Microcephaly Mental Retardation Other: Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for 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.

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Study Type : Observational
Estimated Enrollment : 440 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Evaluation of Fetal Nervous System and Neurodevelopment Disorders in Infants of Women Exposed to Zika Virus Infection During Pregnancy
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV
Other: Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV
Asymptomatic pregnant women with a negative RT-PCR ZIKV in serum and urine, and a negative specific serology for ZIKV at enrollment into the study and at the time of delivery

Primary Outcome Measures :
  1. Neurodevelopmental Outcome [ Time Frame: 24 months corrected age ]
    Bayley Scales of Infant and Toddler Development Third Edition

Secondary Outcome Measures :
  1. Fetal CNS Impairment [ Time Frame: Until Birth ]
    Prenatal Level III Ultrasound Identification of Fetal CNS Abnormalities

Biospecimen Retention:   Samples Without DNA
Maternal serum Amniotic Fluid Urine CSF

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ZIKV symptomatic and asymptomatic pregnant women in hyper endemic areas of ZIKV in Colombia

Inclusion Criteria:

  1. Pregnant women who on their first prenatal visit (independent of gestational age) confirm through a pre-designed questionnaire that they have had any symptom(s) compatible with ZIKV infection (rash [exanthema or sprout], conjunctivitis, arthralgia or myalgia, fever). Pregnant women with an affirmative response will be categorized in two groups:

    • Acute Infection: symptoms of ZIKV infection that occurred within the previous 14 days of the day the pregnant women attended her prenatal visit.
    • Late Infection: symptoms of ZIKV infection that occurred more then 14 days from her prenatal visit. Gestational age of onset of symptomatology will be documented at this time.
  2. Pregnant women without symptoms of ZIKV infection who have a negative RT-PCR for ZIKV and a negative specific serologic test for ZIKV at initial prenatal visit with normal prenatal evaluation. These pregnant women will be selected from non high-risk delivery services.

Exclusion Criteria:

  1. Eligible pregnant women that refuse to sign consent for participation in the ZEN Initiative.
  2. Enrolled pregnant women that withdraw their consent to participate at any time in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02943304

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Contact: Mario A Rojas, MD, MPH 577634000 ext 3301
Contact: Luis A Diaz, MD, MSc 577634000 ext 3301

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Hospital Universitario de Santander Recruiting
Bucaramanga, Santander, Colombia, 68001
Contact: Mario A Rojas, MD,MPH    57763400 ext 3301   
Principal Investigator: Luz A Gutierrez, MD         
Sub-Investigator: Carlos H Becerra, MD         
Sub-Investigator: Luis A Diaz, MD, MSc         
Sub-Investigator: Mario A Rojas, MD, MPH         
Sub-Investigator: Luis A Perez, MD         
Sub-Investigator: Gustavo A Contreras, MD         
Sub-Investigator: Stella Pinilla, MSc         
Sub-Investigator: Luis A Villar, MD, MSc         
Sub-Investigator: Carol G Rueda, MD         
Sponsors and Collaborators
Universidad Industrial de Santander
University of North Carolina, Chapel Hill
Michigan State University
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Principal Investigator: Mario A Rojas, MD, MPH Professor of Pediatrics
Study Director: Luz A Gutierrez, MD Universidad Industrial de Santander
Study Chair: Luis A Diaz, MD, MSc Universidad Industrial de Santander
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Responsible Party: Mario Augusto Rojas, Professor of Pediatrics, Universidad Industrial de Santander Identifier: NCT02943304    
Other Study ID Numbers: 4110
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mario Augusto Rojas, Universidad Industrial de Santander:
Fetal Development
Child Development
Developmental Disabilities
Zika Virus Infection
Additional relevant MeSH terms:
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Zika Virus Infection
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders
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
Congenital Abnormalities