Trial record 2 of 208408 for:    ALL

Cytomegalovirus Testing and Intervention Protocol for Newborn Nursery and Newborn Intensive Care Unit (CMV Screening)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2016 by University of Nebraska
Information provided by (Responsible Party):
Ann Anderson Berry, MD, University of Nebraska Identifier:
First received: February 8, 2016
Last updated: NA
Last verified: February 2016
History: No changes posted


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 infection will then be referred for repeat audiology exam to confirm hearing loss and to Pediatric Infectious Diseases for evaluation and treatment if necessary. Parents or guardians of infants who test positive for cCMV will receive counseling on the importance of following up with these specialists. The primary outcomes measured will be cCMV prevalence data and time to referral and intervention.

Follow up:

Follow-up will be as clinically indicated and determined by the infant's primary care provider, pediatric infectious disease physician, and audiologist. It will not be determined by the study, referral to these services will be the study endpoint.

Condition Intervention
Congenital CMV Infection
Other: Education of parents to pursue prompt hearing screening.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Cytomegalovirus Testing and Intervention Protocol for Newborn Nursery and Newborn Intensive Care Unit

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Feasibility of in hospital screening of well newborns who fail the hearing screen for cCMV [ Time Frame: One month ] [ Designated as safety issue: No ]
    We will evaluate the ability of this intervention to decrease the time to the first hearing screen.

Estimated Enrollment: 60
Study Start Date: March 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group

Patients who fail newborn hearing screen will be screened for CMV by saliva PCR. If positive they will be referred for early hearing screen follow-up and early intervention.

They will also receive a consult with PEdiatric Infectious Disease to evaluate need for treatment.

Intervention:Education of parents to pursue prompt hearing screening.

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.

  Show Detailed Description


Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient with passed hearing screen or patient older than 14 days of life.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02680743

Contact: Ann L Anderson Berry, MD, PhD 402-559-9280

Sponsors and Collaborators
University of Nebraska
Principal Investigator: Ann Anderson Berry UNMC
  More Information

No publications provided

Responsible Party: Ann Anderson Berry, MD, Associate Professor, Peduatrics, University of Nebraska Identifier: NCT02680743     History of Changes
Other Study ID Numbers: 828-15-EP 
Study First Received: February 8, 2016
Last Updated: February 8, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections
Virus Diseases processed this record on February 10, 2016