Zika VirusNCT04398901
Neurodevelopmental Outcomes in ZIKV-Exposed Children
An observational study of Zika Virus and Congenital Zika Syndrome, run by Children's National Research Institute at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Zika Virus, Congenital Zika Syndrome, Congenital Infection
- What is being tested?
- Neurodevelopmental assessments
- How many people
- 204 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Nov 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Zika-exposed children at 3-4 years of age (will be enrolled and studied up to age 8 years) Non-exposed controls at 4 to 5 years of age
Who may be able to join
- 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)
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Developmental Outcome After In Utero ZIKV Exposure in Children Without Congenital Zika Syndrome
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.
Read the detailed description
Zika-virus (ZIKV) infection in pregnancy can result in severe brain damage in 4-12% of cases. Children exposed to ZIKV in utero during the years of 2015-2017 are now in early childhood. Children with severe neurologic injury (Congenital Zika Syndrome; CZS) have a poor developmental outcome, however the developmental outcome of apparently normal infants following in utero ZIKV-exposure is not well known. The incidence of abnormal neurodevelopmental outcome in apparently normal children with in utero ZIKV-exposure is not known.
The investigators will determine if neurodevelopmental assessment scores in children exposed to ZIKV in utero who are normal appearing differ from norms. The investigators hypothesize that ZIKV-exposed normal appearing children will have lower multi-domain developmental assessment scores compared to normative samples. The investigators hypothesize that the presence of mild postnatal non-specific cranial US findings is associated with persistent lower developmental assessment scores compared to ZIKV-exposed children who had normal cranial US and quantitative imaging will find structural and functional brain differences between ZIKV-exposed children and controls..
The investigators will perform a prospective developmental outcome study at 2 sites: 1) Department of Atlántico, Colombia through collaboration with BIOMELAB, the research center of Dr. Carlos Cure, and 2) Children's National, Washington, DC.
The objective of the study is to determine whether children who were exposed to ZIKV in utero and who do not have CZS have abnormalities in neurodevelopment during early childhood and at school age.
The primary outcome at early childhood will be neurodevelopmental assessment scores at age 3 and 4 years. Scores will be compared between Zika-exposed children and controls. The primary outcome at school age will be neurodevelopmental assessment scores at age 5 and 7 years and quantitative brain MRI at 7 years.
- Being tested
- Neurodevelopmental assessments
- Keywords
- ZIKV
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental assessmentsOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neurodevelopmental assessments | |
| 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. Receives: Other: Neurodevelopmental assessments | |
| 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. Receives: Other: Neurodevelopmental assessments | |
| United States Non-ZIKV exposed control | The investigators will enroll 32 non-ZIKV exposed children, age 4 years, in Washington, DC. Receives: Other: Neurodevelopmental assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental assessment at age 4 years
PEDI-CAT score
Measured: 4 years of age
Executive function
BRIEF-2 score
Measured: 5 and 7 years of age
Motor function assessment
MABC-2 score
Measured: 5 and 7 years of age
Brain maturation
Quantitative brain MRI volumetric measurement
Measured: 7 years of age
Secondary outcomes (2)
Motor function assessment
MABC-2 score
Measured: 4 years of age
Intellectual ability
Age-appropriate Wechsler
Measured: 5 and 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start23 Nov 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Zika VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sarah Mulkey, Children's National Research Institute
- Investigators
- Sarah B Mulkey, MD, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398901
- Sponsor's protocol ID
- Pro00012759
- Other IDs
- 1R01HD102445-01
- Status last verified
- Jun 2025
- First submitted
- 19 May 2020
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this time
Publications
Mulkey SB, Peyton C, Ansusinha E, Corn E, Arroyave-Wessel M, Zhang A, Biddle C, Gutierrez C, Sorkar A, Cure A, Cure D, du Plessis AJ, DeBiasi RL, Msall ME, Cure C. Preschool neurodevelopment in Zika virus-exposed children without congenital Zika syndrome. Pediatr Res. 2023 Jul;94(1):178-184. doi: 10.1038/s41390-022-02373-5. Epub 2022 Nov 30.
PubMed 36446920Mulkey SB, Corn E, Williams ME, Peyton C, Andringa-Seed R, Arroyave-Wessel M, Vezina G, Bulas DI, Podolsky RH, Msall ME, Cure C. Neurodevelopmental Outcomes of Normocephalic Colombian Children with Antenatal Zika Virus Exposure at School Entry. Pathogens. 2024 Feb 13;13(2):170. doi: 10.3390/pathogens13020170.
PubMed 38392908Corn E, Andringa-Seed R, Williams ME, Arroyave-Wessel M, Tarud R, Vezina G, Podolsky RH, Kapse K, Limperopoulos C, Berl MM, Cure C, Mulkey SB. Feasibility and success of a non-sedated brain MRI training protocol in 7-year-old children from rural and semi-rural Colombia. Pediatr Radiol. 2024 Aug;54(9):1513-1522. doi: 10.1007/s00247-024-05964-y. Epub 2024 Jul 6.
PubMed 38970708Mulkey SB, Corn E, Williams ME, Ansusinha E, Podolsky RH, Arroyave-Wessel M, Vezina G, Peyton C, Msall ME, DeBiasi RL. Neurodevelopmental Outcomes of Preschoolers with Antenatal Zika Virus Exposure Born in the United States. Pathogens. 2024 Jun 27;13(7):542. doi: 10.3390/pathogens13070542.
PubMed 39057769Mulkey SB, Arroyave-Wessel M, Peyton C, Ansusinha E, Gutierrez C, Sorkar A, Cure A, Samper Y, Cure D, Msall ME, Cure C. Harnessing the power of telemedicine to accomplish international pediatric outcome research during the COVID-19 pandemic. J Telemed Telecare. 2024 Feb;30(2):388-392. doi: 10.1177/1357633X211063166. Epub 2021 Dec 28.
PubMed 34962177Mulkey SB, Williams ME, Peyton C, Arroyave-Wessel M, Berl MM, Cure C, Msall ME. Understanding the multidimensional neurodevelopmental outcomes in children after congenital Zika virus exposure. Pediatr Res. 2024 Aug;96(3):654-662. doi: 10.1038/s41390-024-03056-z. Epub 2024 Mar 4.
PubMed 38438554Williams ME, Corn EA, Martinez Ransanz S, Berl MM, Andringa-Seed R, Mulkey SB. Neurodevelopmental assessments used to measure preschoolers' cognitive development in Latin America: a systematic review. J Pediatr Psychol. 2024 May 16;49(5):321-339. doi: 10.1093/jpepsy/jsad089.
PubMed 38244996Mulkey SB, Andringa-Seed R, Corn E, Williams ME, Arroyave-Wessel M, Podolsky RH, Peyton C, Msall ME, Cure C, Berl MM. School-age child neurodevelopment following antenatal Zika virus exposure. Pediatr Res. 2025 Nov;98(5):1856-1863. doi: 10.1038/s41390-025-03981-7. Epub 2025 Mar 19.
PubMed 40108430Mulkey 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. No abstract available.
PubMed 32274991Mulkey 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.
PubMed 30476967Mulkey 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.
PubMed 31904798Mulkey 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.
PubMed 33872214
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Outcome After In Utero ZIKV Exposure in Children Without Congenital Zika Syndrome
- ClinicalTrials.gov ID
- NCT04398901
- Acronym / sponsor ID
- Pro00012759
- Keywords
- ZIKV
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Zika-virus (ZIKV) infection in pregnancy can result in severe brain damage in 4-12% of cases. Children exposed to ZIKV in utero during the years of 2015-2017 are now in early childhood. Children with severe neurologic injury (Congenital Zika Syndrome; CZS) have a poor developmental outcome, however the developmental outcome of apparently normal infants following in utero ZIKV-exposure is not well known. The incidence of abnormal neurodevelopmental outcome in apparently normal children with in utero ZIKV-exposure is not known.
The investigators will determine if neurodevelopmental assessment scores in children exposed to ZIKV in utero who are normal appearing differ from norms. The investigators hypothesize that ZIKV-exposed normal appearing children will have lower multi-domain developmental assessment scores compared to normative samples. The investigators hypothesize that the presence of mild postnatal non-specific cranial US findings is associated with persistent lower developmental assessment scores compared to ZIKV-exposed children who had normal cranial US and quantitative imaging will find structural and functional brain differences between ZIKV-exposed children and controls..
The investigators will perform a prospective developmental outcome study at 2 sites: 1) Department of Atlántico, Colombia through collaboration with BIOMELAB, the research center of Dr. Carlos Cure, and 2) Children's National, Washington, DC.
The objective of the study is to determine whether children who were exposed to ZIKV in utero and who do not have CZS have abnormalities in neurodevelopment during early childhood and at school age.
The primary outcome at early childhood will be neurodevelopmental assessment scores at age 3 and 4 years. Scores will be compared between Zika-exposed children and controls. The primary outcome at school age will be neurodevelopmental assessment scores at age 5 and 7 years and quantitative brain MRI at 7 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Colombia ZIKV-exposed | – | Other: Neurodevelopmental assessmentsSeventy 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. |
| Colombia Non-ZIKV exposed control | – | Other: Neurodevelopmental assessmentsThe 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. |
| United States ZIKV-exposed | – | Other: Neurodevelopmental assessmentsThe 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. |
| United States Non-ZIKV exposed control | – | Other: Neurodevelopmental assessmentsThe investigators will enroll 32 non-ZIKV exposed children, age 4 years, in Washington, DC. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Zika-exposed children at 3-4 years of age (will be enrolled and studied up to age 8 years) Non-exposed controls at 4 to 5 years of age
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (17 listed)
- another diagnosis that would impact neurodevelopment
- abnormal brain MRI (non-specific mild findings are not an exclusion criteria)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental assessmentsThe 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. | Other | Colombia Non-ZIKV exposed control, Colombia ZIKV-exposed, United States Non-ZIKV exposed control, United States ZIKV-exposed |
Primary outcome
Neurodevelopmental assessment at age 4 years
Time frame: 4 years of age
PEDI-CAT score
Executive function
Time frame: 5 and 7 years of age
BRIEF-2 score
Motor function assessment
Time frame: 5 and 7 years of age
MABC-2 score
Brain maturation
Time frame: 7 years of age
Quantitative brain MRI volumetric measurement
2 secondary outcomes
Motor function assessment
Time frame: 4 years of age
Intellectual ability
Time frame: 5 and 7 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 36446920Mulkey SB, Peyton C, Ansusinha E, Corn E, Arroyave-Wessel M, Zhang A, Biddle C, Gutierrez C, Sorkar A, Cure A, Cure D, du Plessis AJ, DeBiasi RL, Msall ME, Cure C. Preschool neurodevelopment in Zika virus-exposed children without congenital Zika syndrome. Pediatr Res. 2023 Jul;94(1):178-184. doi: 10.1038/s41390-022-02373-5. Epub 2022 Nov 30.
- Results publication: PubMed 38392908Mulkey SB, Corn E, Williams ME, Peyton C, Andringa-Seed R, Arroyave-Wessel M, Vezina G, Bulas DI, Podolsky RH, Msall ME, Cure C. Neurodevelopmental Outcomes of Normocephalic Colombian Children with Antenatal Zika Virus Exposure at School Entry. Pathogens. 2024 Feb 13;13(2):170. doi: 10.3390/pathogens13020170.
- Results publication: PubMed 38970708Corn E, Andringa-Seed R, Williams ME, Arroyave-Wessel M, Tarud R, Vezina G, Podolsky RH, Kapse K, Limperopoulos C, Berl MM, Cure C, Mulkey SB. Feasibility and success of a non-sedated brain MRI training protocol in 7-year-old children from rural and semi-rural Colombia. Pediatr Radiol. 2024 Aug;54(9):1513-1522. doi: 10.1007/s00247-024-05964-y. Epub 2024 Jul 6.
- Results publication: PubMed 39057769Mulkey SB, Corn E, Williams ME, Ansusinha E, Podolsky RH, Arroyave-Wessel M, Vezina G, Peyton C, Msall ME, DeBiasi RL. Neurodevelopmental Outcomes of Preschoolers with Antenatal Zika Virus Exposure Born in the United States. Pathogens. 2024 Jun 27;13(7):542. doi: 10.3390/pathogens13070542.
- Results publication: PubMed 34962177Mulkey SB, Arroyave-Wessel M, Peyton C, Ansusinha E, Gutierrez C, Sorkar A, Cure A, Samper Y, Cure D, Msall ME, Cure C. Harnessing the power of telemedicine to accomplish international pediatric outcome research during the COVID-19 pandemic. J Telemed Telecare. 2024 Feb;30(2):388-392. doi: 10.1177/1357633X211063166. Epub 2021 Dec 28.
- Results publication: PubMed 38438554Mulkey SB, Williams ME, Peyton C, Arroyave-Wessel M, Berl MM, Cure C, Msall ME. Understanding the multidimensional neurodevelopmental outcomes in children after congenital Zika virus exposure. Pediatr Res. 2024 Aug;96(3):654-662. doi: 10.1038/s41390-024-03056-z. Epub 2024 Mar 4.
- Results publication: PubMed 38244996Williams ME, Corn EA, Martinez Ransanz S, Berl MM, Andringa-Seed R, Mulkey SB. Neurodevelopmental assessments used to measure preschoolers' cognitive development in Latin America: a systematic review. J Pediatr Psychol. 2024 May 16;49(5):321-339. doi: 10.1093/jpepsy/jsad089.
- Results publication: PubMed 40108430Mulkey SB, Andringa-Seed R, Corn E, Williams ME, Arroyave-Wessel M, Podolsky RH, Peyton C, Msall ME, Cure C, Berl MM. School-age child neurodevelopment following antenatal Zika virus exposure. Pediatr Res. 2025 Nov;98(5):1856-1863. doi: 10.1038/s41390-025-03981-7. Epub 2025 Mar 19.
- Results publication: PubMed 32274991Mulkey 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. No abstract available.
- Results publication: PubMed 30476967Mulkey 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.
- Results publication: PubMed 31904798Mulkey 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.
- Results publication: PubMed 33872214Mulkey 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.
- Individual participant dataSharing planned: Undecided. Undecided at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah B Mulkey, MD, PhD principal investigator
Children's National Research Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zika Virus and Congenital Zika Syndrome, run by Children's National Research Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental assessment at age 4 years (time frame: 4 years of age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398901, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.