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

NCT04118738 | Completed

• 1 other identifier: ZIP 2.0
• Study Type: observational
• Target: 272
• Locations: 4 countries
• Sites: 5

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.

Conditions

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

Keywords

ZIKA

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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).

  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).

  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).

  Twenty four months after enrollment

Secondary Outcomes (28)

• Anthropometric Measurements: Height

  At enrollment

• Anthropometric Measurements: Height

  Six months after enrollment

• Anthropometric Measurements: Height

  Twelve months after enrollment

• Anthropometric Measurements: Height

  Eighteen months after enrollment

• Anthropometric Measurements: Height

  Twenty-four months after enrollment

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Westat: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Oswaldo Cruz Foundation: collaborator

Study Sites (5)

Departamento de Medicina Tropical da Universidade Federal de Pernambuco- UFPE

Recife, Pernambuco, 50670-901, Brazil

Location

Instituto Fernandes Figueira - FIOCRUZ

Rio de Janeiro, 22250-020, Brazil

Location

Centro Médico Imbanaco (CMI)

Cali, 760031, Colombia

Location

Asociación Civil Selva Amazónica

Iquitos, Loreto, 16001, Peru

Location

Puerto Rico Medical Center- Maternal Infant Studies Center (CEMI)

San Juan, 00936, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine samples

MeSH Terms

Conditions

Zika Virus Infection; Hearing Loss; Eye Abnormalities

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Deolinda MF Scalabrin, MD, PhD

  Research Center- FIOCRUZ Brazil

  STUDY CHAIR

• Marisa M. Mussi-Pinhata, MD, MD

  Ribeirão Preto Medical School- University of Sao Paulo

  STUDY CHAIR

• Maria Elisabeth L Moreira, MD

  Instituto Fernandes Figueira - FIOCRUZ

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: October 8, 2019
• Study Start: June 12, 2019
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

PR (1); BR (2); CO (1); PE (1)