Neurodevelopmental Outcomes in ZIKV-Exposed Children

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT04398901
Status
Enrolling By Invitation

Conditions

  • Child Development
  • Congenital Infection
  • Congenital Zika Syndrome
  • Zika Virus

Eligibility Criteria

Sex
ALL
Age
3 Years - 7 Years
Healthy Volunteers
Accepted

Interventions

  • Neurodevelopmental assessments — OTHER
    The investigators will evaluate multiple domains of neurodevelopment at age 3, 4, 5 and 7 years using parental questionnaires and child exams. At age 7 years, the children will have a non-sedated quantitative brain MRI.

Study Details

In this study the investigators will follow the neurodevelopmental outcome of children with in utero ZIKV exposure who do not have microcephaly or severe abnormalities consistent with Congenital Zika Syndrome. The ZIKV-exposed children will be compared to non-ZIKV exposed controls. Children will be assessed at age 3 and 4 years using standardized neurodevelopmental assessments. Children will also have neurodevelopmental assessment at age 5 and 7 years along with a brain MRI at age 7 years.

Key Dates

Start date
Nov 23, 2020
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
204 participants (estimated)

Arms

  • Arm: Colombia ZIKV-exposed
    Seventy children in Colombia were previously enrolled as part of a fetal-neonatal neuroimaging study in 2016-2017 and were from Department of Atlantico, Colombia on the Caribbean coast. Eligible children had prior normal fetal MRI and fetal US, normal birth head circumference, normal clinical exam, no more than mild non-specific postnatal imaging findings, and are thus without findings of CZS.
  • Arm: Colombia Non-ZIKV exposed control
    The investigators will enroll 70 non-ZIKV exposed children, age 4 to 5 years, in Department of Atlántico, Colombia with birth dates prior to March 31, 2016. Based on the arrival of ZIKV to Colombia in November 2015, this date would ensure a control cohort without congenital ZIKV exposure in the first half of gestation and unlikely during any of the pregnancy.
  • Arm: United States ZIKV-exposed
    The US cohort either presented during pregnancy or after birth and sought clinical care with the Children's National Congenital Zika Program in Washington, DC and were ZIKV-exposed.
  • Arm: United States Non-ZIKV exposed control
    The investigators will enroll 32 non-ZIKV exposed children, age 4 years, in Washington, DC.

Primary Outcome Measure

Neurodevelopmental assessment at age 4 years [ Time Frame: 4 years of age ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010-

Find similar trials in Washington D.C., DC

By research site
Children's National Hospital· Washington D.C., DC

Related Studies