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

• ClinicalTrials.gov Identifier: NCT02680743
• Recruitment Status: Completed
• First Posted: February 11, 2016
• Last Update Posted: October 12, 2018
• Sponsor: University of Nebraska
• Information provided by (Responsible Party): Ann Anderson Berry, MD, University of Nebraska

Study Description

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 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 or disease	Intervention/treatment	Phase
Congenital CMV Infection	Other: Education of parents to pursue prompt hearing screening.	Not Applicable

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Cytomegalovirus Testing and Intervention Protocol for Newborn Nursery and Newborn Intensive Care Unit
• Study Start Date: March 2016
• Actual Primary Completion Date: May 2018
• Actual Study Completion Date: May 2018

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of in hospital screening of well newborns who fail the hearing screen for cCMV [ Time Frame: One month ]
   We will evaluate the ability of this intervention to decrease the time to the first hearing screen.

Eligibility Criteria

• Ages Eligible for Study: up to 14 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Locations

United States, Nebraska

Nebraska Medicine Bellevue

Bellevue, Nebraska, United States, 68123

Nebraska Medicine

Omaha, Nebraska, United States, 68198

Sponsors and Collaborators

University of Nebraska

Investigators

• Principal Investigator: Ann Anderson Berry; UNMC

More Information

• Responsible Party: Ann Anderson Berry, MD, Associate Professor, Peduatrics, University of Nebraska
• ClinicalTrials.gov Identifier: NCT02680743 History of Changes
• Other Study ID Numbers: 828-15-EP
• First Posted: February 11, 2016
• Last Update Posted: October 12, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases