Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants
Public ClinicalTrials.gov record NCT03107871. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants: ValEAR Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The overall goal of this study is to determine the clinical benefit and safety of antiviral therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants. We will conduct a multi-center double-blind randomized placebo-controlled trial to determine whether hearing-impaired infants with asymptomatic cCMV have better hearing and language outcomes if they receive valganciclovir antiviral treatment. We will also determine the safety of antiviral valganciclovir therapy for asymptomatic cCMV-infected hearing impaired infants. This study will be unique in that the cohort enrolled will only include hearing-impaired infants with asymptomatic cCMV. Primary Objective: To determine if treatment of cCMV-infected hearing impaired infants with isolated hearing loss with the antiviral drug valganciclovir reduces the mean slope of total hearing thresholds over the 20 months after randomization compared to untreated cCMV-infected infants with isolated hearing loss. Main Secondary Objectives: 1. To determine if valganciclovir treatment improves the following outcomes when compared to the control group: 1. The slope of best ear hearing thresholds over the 20 months after randomization. 2. The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for words produced at 20 months of age. 2. To evaluate safety measures based on all grade 3 or greater new adverse events designated by the NIAID Division of AIDS (DAIDS) toxicity tables.
Study identification
- NCT ID
- NCT03107871
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 10 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 1 Month to 12 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2018 (Actual)
- Primary completion
- Aug 31, 2022 (Actual)
- Completion
- Aug 31, 2022 (Actual)
- Last update posted
- Aug 27, 2026
2018 – 2022
United States locations
- U.S. sites
- 30
- U.S. states
- 21
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lucile Packard Children's Hospital | Palo Alto | California | 94304 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Massachusetts Eye and Ear | Boston | Massachusetts | 02114 | — |
| Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55455 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Saint Louis Universtiy | St Louis | Missouri | 63103 | — |
| Children's Hospital at Dartmouth-Hitchcock | Lebanon | New Hampshire | 03756 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Weill Cornell Medicine | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Cohen Children's Medical Center | New York | New York | 11040 | — |
| The Children's Hospital at Montefiore | The Bronx | New York | 10469 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
| UT Southwestern | Dallas | Texas | 75235 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84132 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03107871, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03107871 live on ClinicalTrials.gov.