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

NCT04182685 | Completed

• 2 other identifiers: CNDR CIRE-16/07/19-099.Ver21R21HD095420-01A1
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Zika Virus

Keywords

Zika virus; neurodevelopment; neurological sequelae

Outcome Measures

Primary Outcomes (7)

• Prevalence of short-term self-reported neurological symptoms among ZIKV-exposed

  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.

  Baseline data were collected at the time of infection between January 2016 and January 2017

• Prevalence of short-term clinically-observed neurological symptoms among ZIKV-exposed

  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).

  Baseline data were collected at the time of infection between January 2016 and January 2017

• Incidence of long-term clinically-observed neurological sequelae

  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).

  Current study visit (between October 2019-December 2020)

• Incidence of long-term self-reported neurological sequelae

  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.

  Current study visit (between October 2019-December 2020)

• Neurocognitive function

  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.

  Current study visit (between October 2019-December 2020)

• Nonverbal Intelligence

  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.

  Current study visit (between October 2019-December 2020)

• Behavioral problems

  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.

  Current study visit (between October 2019-December 2020)

Secondary Outcomes (3)

• Depression

  Current study visit (between October 2019-December 2020)

• Anxiety

  Current study visit (between October 2019-December 2020)

• Sleep problems

  Current study visit (between October 2019-December 2020)

Study Arms (2)

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.

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RTI International: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of North Carolina, Chapel Hill: collaborator
• Sustainable Sciences Institute (Managua, Nicaragua): collaborator
• Ministry of Health Nicaragua: collaborator

Study Sites (1)

Health Center Socrates Flores Vivas

Managua, Nicaragua

Location

Related Publications (6)

• Schrank FA, McGrew KS, Ruef ML, Alvarado CG. Batería III Woodcock-Muñoz™. Assessment Service Bulletin. 2005(1).

  BACKGROUND

• Achenbach TM, Ruffle TM. The Child Behavior Checklist and related forms for assessing behavioral/emotional problems and competencies. Pediatr Rev. 2000 Aug;21(8):265-71. doi: 10.1542/pir.21-8-265. No abstract available.

  PMID: 10922023 BACKGROUND

• Brown L, Sherbenou RJ, Johnsen SK. TONI-4, Test of Nonverbal Intelligence. Pro-ed; 2010.

  BACKGROUND

• Davanzo P, Kerwin L, Nikore V, Esparza C, Forness S, Murrelle L. Spanish translation and reliability testing of the Child Depression Inventory. Child Psychiatry Hum Dev. 2004 Fall;35(1):75-92. doi: 10.1023/b:chud.0000039321.56041.cd.

  PMID: 15626326 BACKGROUND

• Orgiles M, Mendez X, Spence SH, Huedo-Medina TB, Espada JP. Spanish validation of the Spence Children's Anxiety Scale. Child Psychiatry Hum Dev. 2012 Apr;43(2):271-81. doi: 10.1007/s10578-011-0265-y.

  PMID: 22086155 BACKGROUND

• Mindell, J.A, and Owens, J. O. A Clinical Guide to Pediatric Sleep: Diagnosis and Management of Sleep Problems. Lippincott Williams & Wilkins, 2015.

  BACKGROUND

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Jill F. Lebov, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 2, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

NI (1)