International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy
Condition: Zika; Neurodevelopmental Abnormality; Hearing Loss; Growth Delay; Eye Abnormalities
MeSH terms: Hearing Loss; Eye Abnormalities; Congenital Abnormalities
Study type: Observational

Summary: 
      The International Cohort Study of Children Born to Women Infected with Zika Virus (ZIKV)
      During Pregnancy study is a prospective, observational, international cohort study of
      children previously enrolled in the ZIP study or other ZIP 2.0 Protocol Team approved
      ZIKV-cohort study that will continue the longitudinal follow-up of children born with
      documented confirmed or presumptive in-utero ZIKV exposure ("ZIKV-exposed" cohort) and
      children born without documented confirmed or presumptive in-utero ZIKV exposure, matched by
      site and birth sex ("ZIKV-unexposed" cohort).

      Follow-up evaluations and assessments will allow for the determination and comparison of
      long-term neurodevelopmental outcomes among in utero ZIKV-exposed and ZIKV-unexposed
      children. Each participant will be followed for about 2 years, beginning at approximately 18
      months through 42 months of age.
    

Detailed description: 
      The International Prospective Observational Cohort Study of Zika in Infants and Pregnancy
      (ZIP) study has leveraged 10 international sites to follow mother-infant dyads prospectively
      in pregnancy and postpartum to determine the incidence and outcomes of Zika Virus (ZIKV)
      infection. The ZIP study has collected demographic, physical, environmental, laboratory, and
      delivery outcome data in relation to mother-infant pairs with and without ZIKV infection.
      Infants born to women enrolled in the ZIP study are followed for 1 year and undergo regular
      physical and neurological assessments to identify clinical or developmental outcomes.

      The International Cohort Study of Children Born to Women Infected with Zika Virus During
      Pregnancy (ZIP 2.0) study will enroll children who themselves or whose biological mothers
      were previously enrolled in the ZIP study and other ZIP 2.0 Protocol Team-approved studies.
      Assessments include growth, neurodevelopmental, audiologic, ophthalmologic, and other
      clinical outcomes. Evaluations will occur about every 6 months over about a 2-year period
      beginning at approximately 18 months of age. Follow-up evaluations and assessments will allow
      for the determination and comparison of long-term neurodevelopmental outcomes among in utero
      ZIKV-exposed and ZIKV-unexposed children.

      After parent(s)/legal guardian(s) permission is obtained for the child's participation in ZIP
      2.0, several means to contact them will be requested. Parents will be asked whether or not
      messages can be left for each of the phone numbers provided and if messages can contain
      information regarding the nature of the study.

      We expect to compare approximately 200 children with documented confirmed or presumptive
      in-utero ZIKV exposure and 200 controls matched by site and birth sex without documented
      confirmed or presumptive in-utero ZIKV exposure at age approximately 18 months, and at age 42
      months.

      The primary objective is to determine the long-term neurodevelopmental outcomes among
      children born with documented confirmed or presumptive in-utero ZIKV exposure. The secondary
      objectives are to compare the long-term effects (e.g., on growth, vision, hearing and
      neurodevelopment) of in-utero ZIKV-exposure compared to unexposed children.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 200 children with confirmed or presumptive in-utero exposure to Zika virus
        and approximately 200 children matched by site and birth sex without confirmed or
        presumptive in-utero exposed to Zika virus.
      
Biospecimen description: 
      blood and urine samples
    
Keywords: ZIKA