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Evaluation of Medical Conditions Associated With Zika Virus Infection in Managua, Nicaragua

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182685
Recruitment Status : Enrolling by invitation
First Posted : December 2, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
Sustainable Sciences Institute (Managua, Nicaragua)
Ministry of Health Nicaragua
Information provided by (Responsible Party):
RTI International

Brief Summary:
Zika virus (ZIKV) infection spread throughout the Americas with devastating consequences. Recent limited evidence suggests the potential for neurological effects associated with postnatally acquired ZIKV infection in humans; however, the impact on children is unknown. The researchers will conduct a longitudinal study of approximately 450 Nicaraguan children who were ages 2-12 in 2016 to evaluate the presence and persistence of neurological symptoms associated with ZIKV infection and to test whether ZIKV-infected children are at greater risk for developing neurological outcomes compared to uninfected children.

Condition or disease
Zika Virus

Show Show detailed description

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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 : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Group/Cohort
ZIKV-exposed children
Children age 5-15 with a positive Zika virus PCR test result.
ZIKV-unexposed children
Children age 5-15 who have not had a Zika virus infection as determined by serological assays.



Primary Outcome Measures :
  1. 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.

  2. 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).

  3. Incidence of long-term clinically-observed neurological sequelae [ Time Frame: Current study visit (between October 2019-June 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).

  4. Incidence of long-term self-reported neurological sequelae [ Time Frame: Current study visit (between October 2019-June 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.

  5. Neurocognitive function [ Time Frame: Current study visit (between October 2019-June 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.

  6. Nonverbal Intelligence [ Time Frame: Current study visit (between October 2019-June 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.

  7. Behavioral problems [ Time Frame: Current study visit (between October 2019-June 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.


Secondary Outcome Measures :
  1. Depression [ Time Frame: Current study visit (between October 2019-June 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.

  2. Anxiety [ Time Frame: Current study visit (between October 2019-June 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.

  3. Sleep problems [ Time Frame: Current study visit (between October 2019-June 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.

Information from the National Library of Medicine

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


Locations
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Nicaragua
Health Center Socrates Flores Vivas
Managua, Nicaragua
Sponsors and Collaborators
RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
Sustainable Sciences Institute (Managua, Nicaragua)
Ministry of Health Nicaragua
Investigators
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Principal Investigator: Jill F. Lebov, PhD RTI International
Publications:
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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: February 5, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RTI International:
Zika virus
neurodevelopment
neurological sequelae
Additional relevant MeSH terms:
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Zika Virus Infection
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections