Screening for Congenital Cytomegalovirus Infection in Newborns (CMV)

Screening for Congenital Cytomegalovirus Infection in Newborns With Failed Hearing Screen or Who Are Small for Gestational Age

Our central hypothesis is that screening newborn infants who either fail their newborn hearing test or have a diagnosis of small for gestational age (SGA) will lead to better identification of infants with congenital CMV infection and enhanced rates of therapeutic intervention. This has the potential to significantly improve outcomes for infants with this common viral infection. This particular cohort of patients have not been well studied locally or regionally. In addition, in view of current legislation that will be effective in January, 2016 this is a timely project that will provide preliminary data for future statewide recommendations around CMV testing of newborn infants. This will be a pilot/feasibility study to obtain preliminary data for an Illinois Department of Public Health (IDPH) Title V grant. Although not guaranteed, preliminary discussions with the IDPH are highly encouraging giving the statewide interest in this topic.

Study Overview

• Status: Completed
• Conditions: Cytomegalovirus Infections
• Intervention / Treatment: Other: Observation

Detailed Description

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) in children in the United States, and is the most frequent known viral cause of mental disability. Approximately one percent of all newborn infants in the United States are infected with CMV. Of those infected, approximately 10% have involvement that is evident at birth (symptomatic congenital CMV disease) with manifestations including microcephaly, central nervous system abnormalities, chorioretinitis, hepatosplenomegaly, and SNHL. The most common sequelae following congenital CMV infection is SNHL and it occurs in up to 50% of infants with symptomatic congenital CMV infection and in 15% of asymptomatic infants. Overall, congenital CMV infection accounts for one-third of all cases of SNHL. Among newborn infants who fail hearing screening, the prevalence of congenital CMV infection is much higher (six to 10%) than the general newborn population (<1%). Since early therapeutic intervention for infants with symptomatic congenital CMV infections improves audiological and neurodevelopmental outcomes early diagnosis is essential for early treatment and maximizing infant outcomes.

The Illinois Legislature passed a bill that was signed into law in August 2015 by Governor Rauner regarding congenital CMV. The main objectives of this law are public education regarding CMV infection and efforts to raise awareness of this infection amongst healthcare providers caring for expectant mothers. This Public Act mandates parents receive information regarding testing opportunities and early intervention services for CMV infection when their newborn infant fails his or her hearing screen. Although this bill does not mandate CMV screening, it does state that the hospitals have to provide information about testing options.

Our central hypothesis is that screening newborn infants who either fail their newborn hearing test or have a diagnosis of small for gestational age (SGA) will lead to better identification of infants with congenital CMV infection and enhanced rates of therapeutic intervention. This has the potential to significantly improve outcomes for infants with this common viral infection. This particular cohort of patients have not been well studied locally or regionally. In addition, in view of current legislation that will be effective in January, 2016 this is a timely project that will provide preliminary data for future statewide recommendations around CMV testing of newborn infants. This will be a pilot/feasibility study to obtain preliminary data for an Illinois Department of Public Health (IDPH) Title V grant. Although not guaranteed, preliminary discussions with the IDPH are highly encouraging giving the statewide interest in this topic.

• Study Type: Observational
• Enrollment (Actual): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newborn infants who either fail their newborn hearing test or have a diagnosis of small for gestational age (SGA)

Description

Inclusion Criteria:

• Viable Infants with a failed hearing screen or a diagnosis of SGA who are born at either St. John's Hospital or MMC at ≥ 28 weeks gestation.

Exclusion Criteria:

• Infants born ≤ 27 weeks gestation, infants who are not SGA, infants who pass their newborn hearing screen.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SGA Infants	Other: Observation; Viable Infants with a failed hearing screen or a diagnosis of SGA who are born at either St. John's Hospital or MMC at ≥ 28 weeks gestation.
Failed Hearing Screen Infants	Other: Observation; Viable Infants with a failed hearing screen or a diagnosis of SGA who are born at either St. John's Hospital or MMC at ≥ 28 weeks gestation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the incidence of congenital CMV infection in neonates with failed hearing screen.	At birth
Measure the incidence of congenital CMV infection in neonates who are SGA.	At birth

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure the proportion of patients that receive therapeutic intervention in 2 groups of patients with congenital CMV infection	First six months of life

Collaborators and Investigators

• Sponsor: Southern Illinois University
• Collaborators: University of Alabama at Birmingham
• Investigators: Principal Investigator: Marcela Rodriguez, MD, SIU School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Herpesviridae Infections; Infections; Communicable Diseases; Cytomegalovirus Infections
• Other Study ID Numbers: ROD-SIU-15-288-CMV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO