International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy

NCT ID: NCT04118738

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 272 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2022-04-15

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 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.

Conditions

Zika; Neurodevelopmental Abnormality; Hearing Loss; Growth Delay; Eye Abnormalities

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ZIKV-Exposed

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.

No interventions assigned to this group

ZIKV-Unexposed

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.
• Minimum 74 weeks of age (approximately 17months) of age at enrollment

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 42 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Oswaldo Cruz Foundation

OTHER

Sponsor Role: collaborator

Westat

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deolinda MF Scalabrin, MD, PhD

Role: STUDY_CHAIR

Research Center- FIOCRUZ Brazil

Marisa M. Mussi-Pinhata, MD, MD

Role: STUDY_CHAIR

Ribeirão Preto Medical School- University of Sao Paulo

Maria Elisabeth L Moreira, MD

Role: STUDY_CHAIR

Instituto Fernandes Figueira - FIOCRUZ

Locations

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

Countries

Brazil; Colombia; Peru; Puerto Rico

Other Identifiers

ZIP 2.0

Identifier Type: -

Identifier Source: org_study_id