Clinical Trial: Cytomegalovirus Testing and Intervention Protocol for Newborn Nursery and Newborn Intensive Care Unit

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

Detailed Summary:

Specific Aim 1: Establish a cCMV testing protocol and demonstrate that this protocol is successful at identifying infants with cCMV who present with hearing abnormality as the first sign of infection.

Specific Aim 2: Demonstrate that a majority of infants who test positive for cCMV at the time of failed hearing screen are referred within 14 days for appropriate confirmatory testing and treatment.

Specific Aim 3: Improve cCMV prevalence data estimates for the State of Nebraska.

Congenital cytomegalovirus (cCMV) affects 20,000-40,000 infants in the United States annually and is the most common congenital viral infection in newborns1. cCMV is the most common non-genetic cause of sensorineural hearing loss (SNHL) in children and it is estimated that the 1 in 10 children with SNHL have cCMV related hearing loss. SNHL is the most common sequela of cCMV infection but the overall disease burden is much greater as cCMV is an important contributor to neurodevelopmental delay2.

The most common physical exam findings for identification of cCMV include petechiae, hepatosplenomegaly, microcephaly, hypotonia, hearing loss, purpura, chorioretinitis, and seizure activity and the most common laboratory findings include elevated AST and ALT, thrombocytopenia, conjugated hyperbilirubinemia, and elevated CSF protein3,4. Infants may also be identified based on radiologic abnormalities including abnormal cranial ultrasound, head CT, and brain MRI that may show cerebral calcifications and ventriculomegaly4. Infants with cCMV infections are categorized as either symptomatic or asymptomatic based on the physical exam, laboratory, and radiologic findings that are present at birth3. Approximately 10%-15% of cCMV cases are classified as symptomatic due
Sponsor: University of Nebraska

Current Primary Outcome: Feasibility of in hospital screening of well newborns who fail the hearing screen for cCMV [ Time Frame: One month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Nebraska

Dates:
Date Received: February 8, 2016
Date Started: March 2016
Date Completion: March 2017
Last Updated: September 19, 2016
Last Verified: September 2016