Evaluation of Medical Conditions Associated With Zika Virus Infection in Managua, Nicaragua
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ClinicalTrials.gov Identifier: NCT04182685 |
Recruitment Status : Unknown
Verified June 2020 by RTI International.
Recruitment status was: Enrolling by invitation
First Posted : December 2, 2019
Last Update Posted : August 21, 2020
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Condition or disease |
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Zika Virus |

Study Type : | Observational |
Estimated Enrollment : | 450 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Evaluation of Medical Conditions Associated With Zika Virus Infection in Managua, Nicaragua |
Actual Study Start Date : | October 1, 2019 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Group/Cohort |
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ZIKV-exposed children
Children age 5-15 with a positive Zika virus PCR test result.
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ZIKV-unexposed children
Children age 5-15 who have not had a Zika virus infection as determined by serological assays.
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- Prevalence of short-term self-reported neurological symptoms among ZIKV-exposed [ Time Frame: Baseline data were collected at the time of infection between January 2016 and January 2017 ]When ill children presented to the Health Center Socrates Flores Vivas (HCSFV) between January 2016 and January 2017, they were tested for Zika virus at that visit and 14-21 days later. A questionnaire was administered to the parent/guardian of the child at both the initial and convalescent visits to ascertain information about the child's recent neurological symptoms (i.e., persistent headaches, muscle weakness, seizures, fainting/blackouts, lethargy/fatigue, and back pain). Self-reported outcome.
- Prevalence of short-term clinically-observed neurological symptoms among ZIKV-exposed [ Time Frame: Baseline data were collected at the time of infection between January 2016 and January 2017 ]When ill children presented to the Health Center Socrates Flores Vivas (HCSFV) between January 2016 and January 2017, they were tested for Zika virus at that visit and 14-21 days later. An extensive clinical exam was conducted at both the initial and convalescent visits to assess neurological symptoms (i.e., paralysis, paresthesia, limb weakness).
- Incidence of long-term clinically-observed neurological sequelae [ Time Frame: Current study visit (between October 2019-December 2020) ]At the current study visit, for both ZIKV-infected and uninfected children, a pediatrician will conduct a neurological exam to assess cranial nerve function and to look for evidence of neurological impairment (e.g., vision, hearing, motor, and sensory impairment).
- Incidence of long-term self-reported neurological sequelae [ Time Frame: Current study visit (between October 2019-December 2020) ]A neurological symptoms questionnaire will be administered by a pediatrician during the clinical exam to ascertain information about neurological symptoms (i.e., paralysis, paresthesia, persistent headaches, muscle weakness, seizures, fainting/blackouts, lethargy/fatigue, and back pain) in the last 6 months. The questionnaire also collects information about changes in vision, hearing, and motor function, as well as difficulty concentrating and fatigue, since January 2016. Patient-reported outcome.
- Neurocognitive function [ Time Frame: Current study visit (between October 2019-December 2020) ]Bateria IV Woodcock-Munoz Cognitive module will be administered by a psychologist to assess neurocognitive functioning. The Bateria IV Woodcock-Munoz assesses comprehension-knowledge, visual-spatial thinking, auditory processing, processing speed, memory, attention, and fluid reasoning. Test scores less than one standard deviation from the instrument's normed mean will be considered 'at-risk' for neurocognitive deficiencies.
- Nonverbal Intelligence [ Time Frame: Current study visit (between October 2019-December 2020) ]The Test of Nonverbal Intelligence 4, which assesses intelligence, aptitude, abstract reasoning, and problem solving with minimal physical response, will be administered by a psychologist. Test scores less than one standard deviation from the instrument's normed mean will be considered 'at-risk' for cognitive deficiency.
- Behavioral problems [ Time Frame: Current study visit (between October 2019-December 2020) ]The Child Behavior Checklist (CBCL) will be administered to the parent/guardian of the child participant to ascertain information about the child's behavior. The CBCL provides a score of Internalizing, Externalizing, and Total Behavior Problems, along with eight clinical domains. Children with scores less than two standard deviations from the test normed mean will be considered 'at-risk' for behavioral problems.
- Depression [ Time Frame: Current study visit (between October 2019-December 2020) ]The Children's Depression Inventory Short Form will be administered to the child by a psychologist to obtain information about depression in children age 7-15. Scores range from 0 to 20 with higher scores indicating more severe depression symptoms. Self-reported outcome.
- Anxiety [ Time Frame: Current study visit (between October 2019-December 2020) ]The Spence Children's Anxiety Scales will be administered to the child by a psychologist to obtain information about anxiety in children age 7-15. The scale assesses six domains of anxiety including generalized anxiety (score rang 0-18), panic/agoraphobia (score range 0-27), social phobia (score range 0-18), separation anxiety (score range 0-18), obsessive compulsive disorder (score range 0-18), and physical injury fears (score rang 0-15). Higher scores indicate more severe anxiety. Self-reported outcome.
- Sleep problems [ Time Frame: Current study visit (between October 2019-December 2020) ]The BEARS sleep questionnaire will be administered to the child, if age 13 or older, or the parent/guardian, if the child is age 12 or younger, to obtain information about disordered sleeping. Self-reported outcome.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 5 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Study participants will be recruited from the Pediatric Dengue Cohort Study (PDCS). The PDCS is based out of the HCSFV, the primary public health center for District II of Managua serving a catchment area of more than 60,000 people. Currently, there are 3,818 active participants in the cohort. PDCS children who presented to HCSFV with fever or illness between January 2016 and January 2017 were tested for ZIKV by RT-PCR. The RT-PCR test results define ZIKV exposure in this study. All children in the cohort come to HCSFV once a year to provide a blood sample, regardless of symptoms.
In 2016 and 2017, these specimens were tested for ZIKV infection using a nonstructural protein 1 (NS1) blockade-of-binding (BOB) ELISA assay for ZIKV. The results of this serological assay define the ZIKV-unexposed population in this study. See 'Eligibility Criteria' for additional information.
Inclusion Criteria:
- 5-15 years of age at the time of enrollment;
- Active in the PDCS
- Complete data on age, sex, and ZIKV status;
- Willingness to participate in the study visit;
- Written parental permission and assent to participate, as appropriate by age.
Exclusion Criteria:
- Children with evidence in their medical charts of a diagnosis of a neurological (e.g., traumatic brain injuries, seizure disorder, stroke) or neurodevelopmental disorder (e.g., ADHD, Autism, Intellectual Disability) before January 2016.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182685
Nicaragua | |
Health Center Socrates Flores Vivas | |
Managua, Nicaragua |
Principal Investigator: | Jill F. Lebov, PhD | RTI International |
Responsible Party: | RTI International |
ClinicalTrials.gov Identifier: | NCT04182685 |
Other Study ID Numbers: |
CNDR CIRE-16/07/19-099.Ver2 1R21HD095420-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | December 2, 2019 Key Record Dates |
Last Update Posted: | August 21, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Zika virus neurodevelopment neurological sequelae |
Virus Diseases Zika Virus Infection Infections Arbovirus Infections |
Vector Borne Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections |