Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Cytomegalovirus Testing and Intervention Protocol for Newborn Nursery and Newborn Intensive Care Unit
Brief Summary:
Objective:
Congenital cytomegalovirus (cCMV) is the most common non-genetic cause of pediatric sensorineural hearing loss (SNHL) and an important cause of neurodevelopmental delay. Infants with cCMV can be symptomatic, asymptomatic, or asymptomatic except for hearing loss. Symptomatic infants may be more readily identified and quickly referred for intervention because they may present with classic common clinical findings, but the majority of infants (85-90%) with cCMV are asymptomatic at birth and do not have the classic clinical, laboratory, or radiologic findings and therefore often have delayed identification and intervention. 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.
The overall objective of this proposed research is to 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.
Eligibility Criteria:
Eligible participants will include newborns in the NBN or NICU who are less than 14 days of life who fail the standard hearing screening.
Interventions and Evaluations Saliva samples will be obtained from participating infants with a mouth swab according to an established protocol. The saliva will then be tested for CMV by qualitative polymerase chain reaction by ARUP Laboratories. Infants who test positive for CMV infect