An observational study in Zika, Neurodevelopmental Abnormality and Hearing Loss, sponsored by Westat. Completed at 5 sites in 4 countries. Open to participants aged 18 Months to 42 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Westat · Observational
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.
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.
78 studies on the registry are indexed under Zika Virus Infection; 8 are open to participants now.
This study's enrollment of 272 is below the median of 600 across 31 observational studies indexed under Zika Virus Infection.
Browse Zika Virus Infection studies →Westat is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
ZIKV- Exposed Inclusion Criteria:
ZIKV-Unexposed Inclusion Criteria:
Exclusion Criteria: Both Exposed and Unexposed Cohorts
Children born to women with documented confirmed or presumptive in-utero ZIKV exposure during pregnancy through delivery or the children's laboratory documentation of confirmed or presumptive in-utero ZIKV exposure within five days of birth.
Children born to women without documented confirmed or presumptive in-utero ZIKV exposure during pregnancy through delivery and the children have no laboratory documentation of confirmed or presumptive in-utero ZIKV exposure at any time prior to ZIP 2.0 enrollment, if testing was performed prior to enrollment.
Neurodevelopmental outcome at age18 months
Neurodevelopment will be measured at age 18 months (entry visit) with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III). The scores indicates how well the child performed compared to a group of children within the same age range.
Time frame: At enrollment
Neurodevelopmental outcome at age 24 months
Neurodevelopment will be measured at age 24 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Time frame: Six months after enrollment
Neurodevelopmental outcome at age 30 months
Neurodevelopment will be measured at age 30 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Time frame: Twelve months after enrollment
Neurodevelopmental outcome at age 36 months
Neurodevelopment will be measured at age 36 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Time frame: Eighteen months after enrollment.
Neurodevelopmental outcome at age 42 months
Neurodevelopment will be measured at age 42 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Time frame: Twenty four months after enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 18 months (entry visit).
Time frame: At enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 24 months
Time frame: Six months after enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 30 months
Time frame: Twelve months after enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 36 months
Time frame: Eighteen months after enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 42 months
Time frame: Twenty-four months after enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 18 months (entry visit).
Time frame: At enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 24 months (entry visit).
Time frame: Six months after enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 30 months (entry visit).
Time frame: Twelve months after enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 36 months (entry visit).
Time frame: Eighteen months after enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 42 months (entry visit).
Time frame: Twenty-four months after enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 18 months (entry visit).
Time frame: At enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 24 months.
Time frame: Six months after enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 30 months.
Time frame: Twelve months after enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 36 months.
Time frame: Eighteen months after enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 42 months.
Time frame: Twenty-four months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 24 months
Time frame: Six months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 18 months
Time frame: At enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 30 months
Time frame: Twelve months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 36 months
Time frame: Eighteen months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 42 months
Time frame: Twenty-four months after enrollment
Hearing assessment: A-verage (in dB HL) of the value of Air-conduction test obtained for all frequencies measured (500Hz, 1000 Hz, 2000Hz and 4000Hz).Audiometry (VRA)
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Hearing assessment: Average (in dB HL) of Bone-conduction test obtained for all frequencies measured (500Hz, 1000 Hz, 2000Hz and 4000Hz).
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Hearing assessment: Proportion of children in different categories of the degree of hearing loss
Proportion of children in different categories of the degree of hearing loss (Normal hearing; Mild hearing loss; Moderate hearing loss; Severe hearing loss; and Profound hearing loss). The degree of hearing loss will be determined by grouping the average of the value of Air-conduction test obtained for all frequencies measured (500Hz, 1000 Hz, 2000Hz and 4000Hz).
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]
Hearing assessment: Proportion of children in different categories of the type of hearing loss
Proportion of children in different categories of the type of hearing loss (Sensorineural hearing loss; Conductive hearing loss; and Mixed hearing loss). The type of hearing loss will be established by comparing the mean of air-conduction levels.
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]
Hearing assessment: Proportion of children with abnormal results in the Otoacustic Emissions test.
Time frame: Time Frame: At enrollment only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment, and 18 months after enrollment.
Comprehensive ophthalmologic evaluation.
General examination of eye structure and assessment of visual function. Composite measure of Visual function based on visual behaviors (with minimum and maximum possible values of -6 and +6, respectively).
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Comprehensive ophthalmologic evaluation
Composite measure of Retina evaluation (with minimum and maximum possible values of -14 and +14, respectively).
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4)
Comprehensive ophthalmologic evaluation
Composite measure of Optic Nerve evaluation (with minimum and maximum possible values of -12 and +12, respectively
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Apr 2022, 34 months.
Of 22 observational studies under Zika Virus Infection, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 52. This study's 34 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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