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

NCT02680743 | Completed

• 1 other identifier: 0828-15-EP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Congenital CMV Infection

Outcome Measures

Primary Outcomes (1)

• Feasibility of in hospital screening of well newborns who fail the hearing screen for cCMV

  We will evaluate the ability of this intervention to decrease the time to the first hearing screen.

  One month

Study Arms (1)

Intervention Group

EXPERIMENTAL

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.

Interventions

Education of parents to pursue prompt hearing screening. OTHER

Parents of patients will be counseled on the risks of hearing loss with a positive screen.

Intervention Group

Eligibility Criteria

• Age: 24 Hours - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

Nebraska Medicine Bellevue

Bellevue, Nebraska, 68123, United States

Location

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Ann L Anderson Berry, MD, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 11, 2016
• Study Start: March 28, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)