Status:
COMPLETED
International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy
Lead Sponsor:
Westat
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Zika
Neurodevelopmental Abnormality
Eligibility:
All Genders
18-42 years
Brief 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 enrol...
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 ...
Eligibility Criteria
Inclusion
- ZIKV- Exposed
- Parent(s)/legal guardian(s) provided written permission for his or her child to participate.
- Participant and/or participant's biological mother previously enrolled in the ZIP study or other ZIKV cohort study approved by the sponsors.
- Participant's biological mother has laboratory documentation of positive ZIKV RNA test results during pregnancy through delivery delivery or the participant has laboratory documentation of ZIKV RNA or serology positive/presumptive positive/equivocal ZIKV test within 5 days of birth according to the ZIKV-exposed definitions included in the ZIP 2.0 inclusion criteria.
- Minimum 74 weeks of age (approximately 17months) of age at enrollment
- ZIKV-Unexposed
- Parent(s)/legal guardian(s) provided written permission for his or her child to participate.
- Previously enrolled in the ZIP study and identified as matching the same birth sex and followed at the same study site as an enrolled ZIKV-exposed participant.
- Laboratory documentation that the participant's biological mother has negative ZIKV RNA test results and no positive ZIKV RNA test results at any time during her pregnancy through delivery.
- Participant did not test ZIKV RNA and/or serology positive presumptive positive or equivocal at any time prior to ZIP 2.0 enrollment, if testing was performed prior to enrollment.
- Minimum 74 weeks of age (approximately 17months) of age at enrollment
Exclusion
- Both Exposed and Unexposed Cohorts
- • Enrolled in other clinical research (including other ZIKV research) requiring blood collection, which in combination with ZIP 2.0 evaluations, would exceed the lesser of 50 mL or 3 mL per kg in an 8-week period and/or blood collection would be required more frequently than two times per week.
Key Trial Info
Start Date :
June 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 15 2022
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT04118738
Start Date
June 12 2019
End Date
April 15 2022
Last Update
April 22 2022
Active Locations (5)
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1
Departamento de Medicina Tropical da Universidade Federal de Pernambuco- UFPE
Recife, Pernambuco, Brazil, 50670-901
2
Instituto Fernandes Figueira - FIOCRUZ
Rio de Janeiro, Brazil, 22250-020
3
Centro Médico Imbanaco (CMI)
Cali, Colombia, 760031
4
Asociación Civil Selva Amazónica
Iquitos, Loreto, Peru, 16001