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.
Study Type
OBSERVATIONAL
Enrollment
272
Departamento de Medicina Tropical da Universidade Federal de Pernambuco- UFPE
Recife, Pernambuco, Brazil
Instituto Fernandes Figueira - FIOCRUZ
Rio de Janeiro, Brazil
Centro Médico Imbanaco (CMI)
Cali, Colombia
Asociación Civil Selva Amazónica
Iquitos, Loreto, Peru
Puerto Rico Medical Center- Maternal Infant Studies Center (CEMI)
San Juan, Puerto Rico
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).]
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.