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Cytomegalovirus Testing and Intervention Protocol for Newborn Nursery and Newborn Intensive Care Unit

NCT02680743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-15

No results posted yet for this study

Summary

Congenital cytomegalovirus (cCMV) is the most common non-genetic cause of pediatric hearing loss and an important cause of neurodevelopmental delay. Symptomatic infants are readily identified and quickly referred for treatment, but the majority of infants (85-90%) with cCMV show no symptoms at birth and therefore do not receive timely treatment. Often, these otherwise asymptomatic infants with cCMV may have early congenital hearing loss and therefore fail the newborn hearing screen, but because they are not specifically identified as having cCMV there is a delay in seeking further audiology exam and treatment of the CMV infection.

This study will investigate how testing newborns for congenital cytomegalovirus infection (cCMV) after a failed newborn hearing screens can improve early identification of cCMV infection and therefore reduce the delay in referral of the newborn to appropriate specialists for intervention.

Conditions

  • Congenital CMV Infection

Interventions

OTHER

Education of parents to pursue prompt hearing screening.

Parents of patients will be counseled on the risks of hearing loss with a positive screen.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Ann L Anderson Berry, MD, PhD · University of Nebraska

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Hours
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-28
Primary Completion
2018-05-01
Completion
2018-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02680743 on ClinicalTrials.gov