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

NCT02943304 | Completed

• 1 other identifier: 4110
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Microcephaly; Mental Retardation

Keywords

Pregnancy; Fetal Development; Child Development; Developmental Disabilities; Zika Virus Infection

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental Outcome

  Bayley Scales of Infant and Toddler Development Third Edition

  24 months corrected age

Secondary Outcomes (1)

• Fetal CNS Impairment

  Until Birth

Study Arms (2)

Exposed

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

Unexposed

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

Interventions

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

Exposed

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

ZIKV symptomatic and asymptomatic pregnant women in hyper endemic areas of ZIKV in Colombia

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Industrial de Santander: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Hospital Universitario de Santander

Bucaramanga, Santander Department, 68001, Colombia

Location

Related Publications (1)

• Diaz-Martinez LA, Rojas MA, Pinilla-Garcia LS, Becerra-Mojica CH, Perez-Vera LA, Gutierrez-Sanchez LA, Contreras-Garcia GA, Rueda-Ordonez CG, Villar L. Neurodevelopmental outcome of infants without central nervous system anomalies born to symptomatic RT-PCR ZIKV positive women. PLoS Negl Trop Dis. 2022 Mar 7;16(3):e0009854. doi: 10.1371/journal.pntd.0009854. eCollection 2022 Mar.

  PMID: 35255097 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal serum Amniotic Fluid Urine CSF

MeSH Terms

Conditions

Microcephaly; Intellectual Disability; Developmental Disabilities; Zika Virus Infection

Interventions

Urination

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Mario A Rojas, MD, MPH

  Professor of Pediatrics

  PRINCIPAL INVESTIGATOR

• Luz A Gutierrez, MD

  Universidad Industrial de Santander

  STUDY DIRECTOR

• Luis A Diaz, MD, MSc

  Universidad Industrial de Santander

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 24, 2016
• Study Start: May 1, 2016
• Primary Completion: December 15, 2020
• Study Completion: December 20, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)