# ZIP 2.0 STUDY CHILD COHORT WITH INTERIM ANALYSIS OF AGE 30 MONTHS DATA

> **NIH NIH N01** · WESTAT, INC. · 2021 · $2,330,566

## Abstract

Zika virus (ZIKV) is an arbovirus (vector-borne virus) of the genus Flaviviridae. Infections
were thought to be mild and self-limiting until 2015, when an epidemic was observed initially
in Brazil of microcephaly and other birth defects in newborns following infection of the
mother during pregnancy with Zika virus (ZIKV). Increasing evidence now 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 (CZS). Whether there are latent effects on growth and development
in infants who are born without CZS to Zika-infected women, and what those effects may be,
is unclear. Longitudinal studies of infants born to Zika-infected pregnant women are needed
to assess the broader spectrum and natural history of possible manifestations of intrauterine or
intrapartum Zika exposure.
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 completed 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, following
children beyond infancy to 42 months of age to evaluate the effects of Zika on child growth
and development.
Recent studies have found that infants who had in utero ZIKV exposure without CZS appear
to be at risk for abnormal neurodevelopmental outcomes in the first 18 months of life1 and
similarly observed high frequencies of anatomical and neurodevelopmental abnormalities in
children without microcephaly who were exposed to ZIKV in utero2. One study found a
gradient of risk of development delay according to head circumference, with severely
microcephalic children at highest risk for delays while normocephalic ZIKV-exposed children
showed similar risk to unexposed control children3. However, several other studies have
observed abnormal neurodevelopment in the absence of microcephaly among children with
intrauterine ZIKV exposure4,5. Those reports indicate that nearly all such children presented at
least one developmental delay and that a significant proportion of children exposed in utero to
ZIKV developed mild cognitive delay and auditory behavioral abnormalities.

## Key facts

- **NIH application ID:** 10396161
- **Project number:** 275201800001I-0-759402100002-1
- **Recipient organization:** WESTAT, INC.
- **Principal Investigator:** BARBARA DRIVER
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $2,330,566
- **Award type:** —
- **Project period:** 2021-04-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10396161

## Citation

> US National Institutes of Health, RePORTER application 10396161, ZIP 2.0 STUDY CHILD COHORT WITH INTERIM ANALYSIS OF AGE 30 MONTHS DATA (275201800001I-0-759402100002-1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10396161. Licensed CC0.

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