# A Randomized Trial to Determine the Role of Valganciclovir for Asymptomatic Cytomegalovirus Infected Hearing Impaired Infants

> **NIH NIH U01** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2020 · $631,810

## Abstract

PROJECT SUMMARY / ABSTRACT
Cytomegalovirus (CMV) can be transmitted from the mother to the fetus and is a leading cause of
sensorineural hearing loss (SNHL), which is a condition where the inner ear is unable to convert sound into
nerve impulses to the brain. This hearing loss and its detrimental effect on language development contribute
nearly $4 billion annually to the health care costs in the U.S. Unlike other types of SNHL, CMV induced hearing
loss can be treated. Several clinical trials have demonstrated that antiviral therapy may prevent progressive
hearing loss if administered early in life for severely affected (symptomatic CMV) infants. These promising
findings have given rise to a debate regarding the best method for identifying and treating less affected but
more numerous (asymptomatic CMV) infants with CMV. One approach is CMV testing only those newborns
who fail their newborn hearing screening. This path has been advocated as a targeted option to identify those
infants at greatest risk to develop progressive hearing loss. Utah is the first state to mandate this approach
whereby infants under three weeks of age who fail their newborn hearing screening undergo CMV testing.
Since we anticipate maximal benefit from antiviral therapy, we will compare the hearing, and language
outcomes of asymptomatic CMV infected valganciclovir (VGC) treated and untreated infants identified via a
hearinglosstargetedearlyCMVapproach(HT-CMV).Thisanalysiswillinformpublicpolicyandpotentiallyshift
our current clinical practice regarding pediatric hearing loss evaluation. In the proposed work, the investigators
will pursue two specific aims: (1) Compare the hearing and language outcomes of asymptomatic CMV-infected
hearing-impaired treated to untreated infants via a multi-institutional double-blinded placebo controlled clinical
trial. (2) To evaluate the safety of antiviral valganciclovir therapy for asymptomatic CMV-infected hearing
impaired infants. This project is directly relevant to the mission of the NIDCD “to support research evaluating
approaches to the identification and treatment of communication disorders and patient outcomes .” More
specifically, in the 2012–2016 NIDCD Strategic Plan, in the Priority Area of Hearing and Balance Research,
Priority Area 4 includes comparative effectiveness research which will inform health care decisions.

## Key facts

- **NIH application ID:** 9976487
- **Project number:** 5U01DC014706-04
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Albert H Park
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $631,810
- **Award type:** 5
- **Project period:** 2017-07-06 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9976487

## Citation

> US National Institutes of Health, RePORTER application 9976487, A Randomized Trial to Determine the Role of Valganciclovir for Asymptomatic Cytomegalovirus Infected Hearing Impaired Infants (5U01DC014706-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9976487. Licensed CC0.

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