MedTrace Logo

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

NCT04118738 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 272

Last updated 2022-04-22

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

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

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Westat

    lead OTHER

Principal Investigators

  • Deolinda MF Scalabrin, MD, PhD · Research Center- FIOCRUZ Brazil

  • Marisa M. Mussi-Pinhata, MD, MD · Ribeirão Preto Medical School- University of Sao Paulo

  • Maria Elisabeth L Moreira, MD · Instituto Fernandes Figueira - FIOCRUZ

Eligibility

Min Age
18 Months
Max Age
42 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-12
Primary Completion
2022-04-15
Completion
2022-04-15

Countries

  • Brazil
  • Colombia
  • Peru
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118738 on ClinicalTrials.gov