Child Development Clinical Trial
Official title:
Developmental Outcome After In Utero ZIKV Exposure in Children Without Congenital Zika Syndrome
Verified date | August 2022 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 204 |
Est. completion date | June 30, 2025 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility | 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 therapy - receiving special education services in school - behavioral or psychological condition - birth date March 31, 2016 or later (Colombian controls) - preterm birth (=36 weeks) - planned relocation of child within 5 years and likely inability to complete study |
Country | Name | City | State |
---|---|---|---|
Colombia | Biomelab | Barranquilla | Atlantico |
United States | Children's National Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's National Research Institute | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Thrasher Research Fund |
United States, Colombia,
Mulkey SB, Ansusinha E, Cristante C, Russo SM, Biddle C, Kousa YA, Pesacreta L, Jantausch B, Hanisch B, Harik N, Hamdy RF, Hahn A, Chang T, Jaafar M, Ambrose T, Vezina G, Bulas DI, Wessel D, du Plessis AJ, DeBiasi RL. Complexities of Zika Diagnosis and Evaluation in a U.S. Congenital Zika Program. Am J Trop Med Hyg. 2021 Apr 19;104(6):2210-2219. doi: 10.4269/ajtmh.20-1256. — View Citation
Mulkey SB, Arroyave-Wessel M, Peyton C, Bulas DI, Fourzali Y, Jiang J, Russo S, McCarter R, Msall ME, du Plessis AJ, DeBiasi RL, Cure C. Neurodevelopmental Abnormalities in Children With In Utero Zika Virus Exposure Without Congenital Zika Syndrome. JAMA Pediatr. 2020 Mar 1;174(3):269-276. doi: 10.1001/jamapediatrics.2019.5204. Erratum in: JAMA Pediatr. 2020 Mar 1;174(3):305. — View Citation
Mulkey SB, Bulas DI, Vezina G, Fourzali Y, Morales A, Arroyave-Wessel M, Swisher CB, Cristante C, Russo SM, Encinales L, Pacheco N, Kousa YA, Lanciotti RS, Cure C, DeBiasi RL, du Plessis AJ. Sequential Neuroimaging of the Fetus and Newborn With In Utero Zika Virus Exposure. JAMA Pediatr. 2019 Jan 1;173(1):52-59. doi: 10.1001/jamapediatrics.2018.4138. — View Citation
Mulkey SB, DeBiasi RL. Do Not Judge a Book by Its Cover: Critical Need for Longitudinal Neurodevelopmental Assessment of In Utero Zika-Exposed Children. Am J Trop Med Hyg. 2020 May;102(5):913-914. doi: 10.4269/ajtmh.20-0197. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurodevelopmental assessment at age 4 years | PEDI-CAT score | 4 years of age | |
Primary | Executive function | BRIEF-2 score | 5 and 7 years of age | |
Primary | Motor function assessment | MABC-2 score | 5 and 7 years of age | |
Primary | Brain maturation | Quantitative brain MRI volumetric measurement | 7 years of age | |
Secondary | Motor function assessment | MABC-2 score | 4 years of age | |
Secondary | Intellectual ability | Age-appropriate Wechsler | 5 and 7 years of age |
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