By InvitationNot Applicable

Neurodevelopmental Outcomes in ZIKV-Exposed Children

United States, Colombia204 participantsStarted 2020-11-23

Plain-language summary

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.

Who can participate

Age range

3 Years – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Zika-exposed cohort: * born to mothers with Zika lab confirmation by PCR, IgM, and/or PRNT, or mother was symptomatic for Zika but infection could not be excluded due to late testing and evaluated at Children's National, Washington, DC (USA) or at BIOMELAB, Barranquilla (Colombia) * normal fetal neuroimaging * normal birth head circumference * normal birth clinical exam * no more than mild non-specific postnatal cranial ultrasound or brain MRI findings during infancy (if performed) * able to be contacted for follow-up Non-ZIKV exposed Controls: * healthy * no chronic medical conditions * no developmental concerns * born at term (\>= 37 weeks) * birth date prior to March 31, 2016 (Colombian controls) Exclusion Criteria: Zika-exposed cohort: * another diagnosis that would impact neurodevelopment * abnormal brain MRI (non-specific mild findings are not an exclusion criteria) Non-ZIKV exposed controls: * chronic medical condition with in-patient hospitalization since birth * under care of a medical specialty provider for a chronic medical condition * surgery with general anesthesia since birth (brief anesthesia for ear tubes, tonsillectomy, or other minor pediatric procedure is not an exclusion criteria) * history of seizure * abnormal vision (children wearing corrective lenses are eligible) * abnormal hearing affecting language development * developmental concerns expressed by caregiver * receiving physical, occupational, speech or developmental ther…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neurodevelopmental assessment at age 4 years

Timeframe: 4 years of age

Executive function

Timeframe: 5 and 7 years of age

Motor function assessment

Timeframe: 5 and 7 years of age

Brain maturation

Timeframe: 7 years of age

Trial details

NCT IDNCT04398901

SponsorChildren's National Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Zika Virus trials