# FOLLOW-UP OF ZIP 2.0 CHILD COHORT WITH INTEGRATION AND ANALYSIS OF DATA AND SAMPLES FROM THE SIKA IN INFANT AND PREGNANCY (ZIP) STUDY.

> **NIH NIH N01** · WESTAT, INC. · 2020 · $2,800,000

## Abstract

Zika virus (ZIKV) is an arbovirus (vector-borne  virus)  of  the  genus  Flaviviridae.  Until recently , infections were thought to be mild and self-limiting. Since 2015 however, ZIKV infections have been associated with an increase in microcephaly and other birth defects in
newborns following infection of the mother during pregnancy. ZIKV also has been associated with Guillain-Barre Syndrome in adults.

Increasing evidence points to ZIKV as the agent responsible for a variety of birth defects in newborns of mothers who become infected during pregnancy . The relationship  of  ZIKV infections in pregnant women with adverse outcomes of pregnancy is the subject of ongoing evaluation. Studies to date of infants born to infected women focus on those born  with serious birth defects that constitute the congenital Zika syndrome. However, whether there are latent effects on growth and development of  infants  who  are  not  born  with  congenital  Zika syndrome, and what those effects may  be,  is  presently  unknown.  Longitudinal  studies  of infants born to Zika-infected pregnant women therefore arc necessary to assess the broader spectrum of possible manifestations of intrauterine or intrapartum Zika  exposure ,  and  their natural history.

In 2016 , NIH initiated a large, multicenter, international observational study of the
epidemiology natural history, and pathogenesis of Zika in infants and pregnancy (the ZIP
Study) . The ZIP Study followed infants born to women at risk for Zika infection during pregnancy only through the infants'  first 12 months of life and will complete  its last patient last visit December 2019. In 2018, NIH initiated the ZIP 2.0 cohort study of Zika exposed children and unexposed control children from the ZIP Study or similar studies beyond infancy into early childhood to evaluate  the effects of Zika on child growth and development. This task order addresses NlH's requirement lo continue follow-up of ZIP 2.0 infants and children and to combine and consolidate into ZIP 2.0 final and complete data and biospecimens from the ZIP study.

SCOPE
To conduct the initial phase of the ZIP 2.0 cohort study of children born to women in the Zika in Infants and Pregnancy (ZIP) Study, including final completion of the ZIP Study and integration and analysis of ZIP Study data and samples into ZIP 2.0. Specifically, this includes: (1) completion and consolidation of ZIP study data and biospecimens into ZIP 2.0 study startup activities and (2) implementation of the initial phase of the ZIP 2.0 Stud y, including services and supp011 related to protocol development, data collection, database preparation, data analysis and preparation of clinical study reports.

## Key facts

- **NIH application ID:** 10151316
- **Project number:** 275201800001I-0-759402000003-1
- **Recipient organization:** WESTAT, INC.
- **Principal Investigator:** BARBARA DRIVERS
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,800,000
- **Award type:** —
- **Project period:** 2020-05-01 → 2021-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10151316

## Citation

> US National Institutes of Health, RePORTER application 10151316, FOLLOW-UP OF ZIP 2.0 CHILD COHORT WITH INTEGRATION AND ANALYSIS OF DATA AND SAMPLES FROM THE SIKA IN INFANT AND PREGNANCY (ZIP) STUDY. (275201800001I-0-759402000003-1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10151316. Licensed CC0.

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