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

Completed · Not applicable

Conditions studied: Congenital CMV Infection

In brief

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.

Key facts

Study ID

NCT02680743

Run by

University of Nebraska

People needed

60

Starts

2016-03-28

Expected to finish

2018-05-01

Last updated by the study team

2023-09-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient that fails initial hearing screen before 14 days of life.

You may not qualify if…

• Patient with passed hearing screen or patient older than 14 days of life.

Where it is running

• Nebraska Medicine Bellevue — Bellevue, Nebraska, United States
• Unversity of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.