Published online May 1, 2008
PEDIATRICS Vol. 121 No. 5 May 2008, pp. 970-975 (doi:10.1542/peds.2006-3441)
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ARTICLE

Newborn Hearing Screening and Detection of Congenital Cytomegalovirus Infection

Elizabeth K. Stehel, MDa, Angela G. Shoup, PhDb, Kristine E. Owen, AuDb, Gregory L. Jackson, MD, MBAa, Dorothy M. Sendelbach, MDa, Linda F. Boney, MT, ASCPc and Pablo J. Sánchez, MDa

Departments of a Pediatrics
b Otolaryngology
c Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
OBJECTIVES. The objectives were to determine the frequency of congenital cytomegalovirus infection among newborns who did not pass hearing screening tests or had confirmed hearing loss and to determine how often abnormal hearing screening results were the only manifestation of congenital cytomegalovirus infection.

METHODS. Retrospective chart review was performed for newborns who had abnormal hearing screening results and positive urine cytomegalovirus culture results at Parkland Memorial Hospital between September 1, 1999, and August 31, 2004.

RESULTS. During the 5-year study period, 572 of 79047 newborns (7 of 1000 live births) did not pass hearing screening tests. Cytomegalovirus infection was identified in 24 (5%) of 483 tested infants and 16 (6%) of the 256 infants with subsequently confirmed hearing impairment. Of those 16 infants, 12 (75%) were identified as having congenital cytomegalovirus infection only because of failure to pass newborn hearing screening tests.

CONCLUSIONS. Congenital cytomegalovirus infection was present for 6% of newborns with confirmed hearing impairment, and the majority of those infants were identified on the basis of abnormal newborn hearing screening results.

Key Words: congenital cytomegalovirus infection • newborn hearing screening

Abbreviations: CMV—cytomegalovirus • PMH—Parkland Memorial Hospital • AABR—automated auditory brainstem response

Hearing impairment occurs in 1 to 3 of 1000 live births in the United States, with an estimated 4000 to 12000 infants being born each year with hearing impairments that may affect speech and language development.1 Congenital infection attributable to cytomegalovirus (CMV) occurs in ~1% of all live births in the United States and is the leading nongenetic cause of hearing impairment in infancy.1

Awareness of the role of CMV in causing sensorineural hearing loss led to the institution of a protocol at Parkland Memorial Hospital (PMH) (Dallas, TX) whereby all newborns who do not pass hearing screening have a urine culture performed for CMV. This study reviews our experience with this policy. Our objectives were to determine the frequency of congenital CMV infection among newborns who did not pass the automated auditory brainstem response (AABR) test or had confirmed hearing loss and, specifically, to determine how often abnormal hearing screening results were the only manifestation of congenital CMV infection.


   METHODS
TOP
 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 
This retrospective study enrolled all infants who were born at PMH between September 1, 1999, and August 31, 2004, and did not pass the AABR hearing screening test before discharge from either the newborn nursery or the NICU. These infants were identified from a proprietary newborn hearing screening database used to manage the newborn hearing screening program.2 Since September 1999, universal newborn hearing screening using AABR testing has been performed for all newborns at PMH, as mandated by Texas state law. PMH, an urban county hospital, is one of the largest single-site birthing hospital in the United States, with an annual birth rate of ~16000 infants. The PMH obstetric population is 79% Hispanic and 15% black, 67% of patients have Medicaid, 2% have commercial insurance, and 95% receive prenatal care.

Newborn hearing screening at PMH is performed by following a standardized protocol.2 Newborn hearing screening is conducted by using the ALGO 2e Color and ALGO 3 AABR systems (Natus Medical, San Carlos, CA), which provide "pass" or "refer" results. The sensitivity of the ALGO 2e Color and ALGO 3 systems is >99%, and the specificity is 96%.3 Infants who do not pass the hearing screening performed by the technician while they are in the nursery are rescreened by an audiologist before discharge. Those who still do not pass undergo outpatient AABR testing, which is performed by an audiologist within 2 weeks after hospital discharge. Infants who do not pass the outpatient AABR test are referred for audiologic evaluation at Children's Medical Center Dallas, to confirm hearing impairment. This evaluation consists of diagnostic auditory brainstem response testing, evoked otoacoustic emissions testing, high-frequency tympanometry, and an examination by a pediatric otolaryngologist.

Urine cultures for detection of CMV infection were performed routinely for infants who (1) did not pass the final inpatient hearing screening performed by an audiologist, (2) were born to mothers infected with HIV, or (3) had clinical or laboratory signs suggesting CMV infection (eg, hepatosplenomegaly, thrombocytopenia, or microcephaly, defined as head circumference of <10th percentile). Infants who had positive urine CMV culture results were identified from the audiology database (Drs Shoup and Owen) and the records of the virology laboratory at the University of Texas Southwestern Medical Center (James Luby, MD, and Ms Boney). Urine cultures for CMV were performed daily by using freshly obtained urine specimens, which were held at 4°C until they were processed in the virology laboratory. A rapid, centrifugation-enhanced, culture technique (shell vial assay) that uses monoclonal antibodies to early antigens was used to identify CMV-infected cells after 24 and 48 hours of incubation.4

The demographic and clinical characteristics of the CMV-infected infants and their mothers were reviewed. Congenital CMV infection was defined as a positive urine CMV culture result obtained within the first 3 weeks of age. The timing of an infant's CMV infection was assessed as being "indeterminate" if the urine culture that yielded CMV was performed after 3 weeks of age and no previous culture had been performed. Acquired CMV infection was defined as a positive CMV culture result with urine collected after 3 weeks of age from an infant who previously had negative culture results. Seven infants had either acquired (n = 2) or indeterminate (n = 5) CMV infections and were excluded from analysis; none had hearing loss. Two additional infants were excluded from the study because they died before hearing screening was performed; 1 infant had congenital CMV infection and the other had acquired CMV disease. The study was approved by the institutional review board of the University of Texas Southwestern Medical Center.


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 CONCLUSIONS
 REFERENCES
 
Between 1999 and 2004, 79047 neonates, or 99% of 79575 live births, had hearing screening performed before nursery discharge (Fig 1). Infants who were not tested were transferred for surgery or extracorporeal membrane oxygenation, died before testing, or had lethal congenital anomalies. Overall, 572 newborns (0.7%) did not pass inpatient AABR screening tests, and 256 (45%) of those, or 0.3% of newborns screened, subsequently demonstrated confirmed hearing impairment.


Figure 1
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  		FIGURE 1 Results of hearing tests and CMV screening at PMH from September 1, 1999 to August 31, 2004.

 
Of the 572 infants who did not pass inpatient hearing screening tests, 483 (84%) had urine cultures performed for CMV, and results were positive for 24 (5%) (Fig 2). Sixteen (67%) of the 24 infants had both congenital CMV infection and confirmed hearing deficits in follow-up testing, representing 6% of the 256 infants with hearing impairment. Of the 16 infants with confirmed hearing impairment, 4 (25%) had clinical signs suggesting a congenital infection that prompted testing for CMV, whereas 12 (75%) were identified as being infected with CMV only because they did not pass the hearing screening tests (Fig 2). In a retrospective review of their medical charts, 4 of the 12 infants identified as being infected with CMV after failing to pass hearing screening tests had other signs suggesting CMV infection (microcephaly, 2 infants; thrombocytopenia, 2 infants).


Figure 2
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  		FIGURE 2 Results of hearing tests and CMV urine cultures at PMH from September 1, 1999 to August 31, 2004. a Infants tested for CMV secondary to failed hearing screen (n = 2), but retrospective chart review revealed microcephaly in 1 infant. b Infants tested for CMV secondary to failed hearing screen (n = 4), but retrospective chart review revealed microcephaly (n = 2) and thrombocytopenia (n = 2).

 
Six (25%) of the 24 CMV-infected infants who did not pass inpatient hearing screening tests had subsequent outpatient hearing test results that were within normal limits (Fig 2). Five of those 6 infants were screened for CMV because of failure to pass inpatient hearing screening tests, and 1 was identified because of clinical signs of infection. Two (8%) of the 24 infants failed repeated AABR hearing screening tests but did not return for confirmatory auditory brainstem response testing. Both of those infants underwent urine CMV testing because they did not pass hearing screening tests. One of the 2 infants who were lost to follow-up monitoring had clinically inapparent CMV infection, and 1 had microcephaly.

Overall, 19 infants (2 who did not return for follow-up testing, 12 who had subsequently confirmed sensorineural hearing deficits, and 5 who had normal hearing in follow-up tests) were identified as having congenital CMV infection on the basis of failure to pass hearing screening tests (Fig 2). The clinical characteristics of the 14 infants with confirmed or possible hearing loss and their mothers are provided in Table 1. Only 2 of the 19 infants had other risk indictors for hearing loss. Both were in the NICU for ≥48 hours and received gentamicin for 7 days, 1 because of pneumonia and the other because of possible sepsis; blood cultures for both infants yielded negative results.


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  		TABLE 1 Clinical Characteristics of the 14 Mothers and Their Infants With Confirmed or Possible Hearing Impairment Who Were Diagnosed as Having Congenital CMV Infection on the Basis of Abnormal Hearing Screening Results

 
Use of our selective criteria to screen newborns for congenital CMV infection resulted in identification of a total of 50 infected infants (Table 2). Specifically, 19 of those infants were screened for CMV because of failure to pass hearing screening tests, 6 infants because of maternal HIV infection, 22 infants because of clinical signs of CMV disease, and 3 infants because of both maternal HIV infection and clinical abnormalities. Of the 50 CMV-infected infants, 30 had clinical signs of congenital CMV infection and underwent hearing screening (22 who had clinical signs alone, 3 who had clinical signs and maternal HIV infection, and 5 who had clinical signs identified in retrospective chart review); 8 (27%) of the 30 infants had confirmed sensorineural hearing loss.


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  		TABLE 2 Indications for Performance of CMV Urine Cultures for 50 Infants With Congenital CMV Infection Identified at PMH Between September 1, 1999, and August 31, 2004

 

   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
CONCLUSIONS
 REFERENCES
 
Each year, an estimated 40000 infants are born with congenital CMV infection in the United States.5 The majority of infected newborns do not have any clinical signs of CMV disease, although as many as 15% develop hearing loss.6,7 Neither the CMV infection nor the hearing loss is detected in these infants unless screening for these conditions is performed.

In 1999, the Texas state legislature mandated universal hearing screening of all newborns, as recommended by the Joint Committee on Infant Hearing.8 The goals were to screen all infants by 1 month of age or before hospital discharge, to identify all infants with hearing impairment by 3 months of age, and to begin intervention by 6 months of age, with the goal of improving language development.8–11 Because of the association of sensorineural hearing loss with congenital CMV infection, we performed CMV testing on all newborns who did not pass hearing screening tests, thus providing parents with a reason for the hearing impairment, as well as prognostic expectations and guidelines for monitoring auditory sensitivity. Our results showed that 6% (16 of 256 infants) of hearing impairment among predominantly Hispanic newborns could be attributed to CMV. Similarly in Italy, Barbi et al12 found that 10% of infants (9 of 87 infants) with sensorineural hearing loss detected at <2 months of age had congenital CMV infection. Those infants were diagnosed through detection of CMV DNA in polymerase chain reaction assays using stored dried blood spot samples from Guthrie cards used for newborn screening. In a follow-up multicenter study of 77 Italian children with sensorineural hearing impairment of >40 dB in either ear, Barbi et al13 found a prevalence of congenital CMV infection of 25%. In Sweden, 10 (0.1%) of 12000 newborns had bilateral sensorineural hearing loss, and congenital CMV infection accounted for more than one third of all hearing loss.14 None of those studies, including ours, evaluated the potential contribution of genetic causes of hearing loss, such as connexin GJB2 and mitochondrial A1555G mutations, or syndromic forms of hearing loss, such as that associated with Pendred syndrome, which together constitute as much as 60% of congenital hearing impairment. None of our 19 infants identified as having congenital CMV infection because of failed hearing screening tests were diagnosed as having syndromes or malformations associated with hearing loss, were tested for genetic mutations, or had a family history of hearing loss. The only other risk indicator for hearing impairment among those infants was a NICU stay of >48 hours for 2 of the infants.8

Hearing impairment in infants with clinically inapparent congenital CMV infection may remain stable, fluctuate, progress, or even develop later in childhood or adolescence.15–19 Use of universal newborn hearing screening as an aid in the detection of congenital CMV infection would not identify CMV-infected children who develop hearing impairment after the newborn period. Studies suggest that detection of CMV DNA in infant blood or umbilical cord in polymerase chain reaction assays, which is a more feasible method than urine or saliva culture to identify infants with congenital CMV infection, ultimately may help identify such children with late-onset hearing loss.20–26 However, the current lack of identifiable predictors for the development of late-onset hearing impairment suggests that all infants with congenital CMV need to be identified. Early identification of hearing impairment coupled with timely intervention improves language development.9–11 The importance of identifying these newborns before they develop hearing loss was highlighted by a study that suggested that ganciclovir therapy may prevent hearing deterioration or maintain normal hearing for ≥1 year in infants with central nervous system manifestations of CMV disease.27

Failure to pass AABR hearing screening tests at birth did help to identify some infants with CMV infection who otherwise would not have been diagnosed. Overall, 75% of the CMV-infected neonates (12 of 16 infants) with hearing impairment were diagnosed as having congenital CMV infection only because of abnormal hearing screening results. The results of this study, however, are limited by its retrospective nature and the lack of universal CMV screening. Another limitation is that only 84% of infants who did not pass the newborn hearing screening tests were tested for CMV infection. Sampling of saliva rather than urine might have improved compliance with our selective screening protocol, because urine often is difficult to obtain and to process for newborns. In addition, retrospective review of the medical charts of infants who were tested for CMV infection because they did not pass the newborn hearing screening tests revealed clinical and laboratory abnormalities that should have prompted performance of a CMV culture.

The incidence of congenital CMV infection in Hispanic infants born in the United States is not known. If it is assumed that the estimated incidence in our population is similar to that found by Noyola et al28 at a single hospital center in Mexico, then ~1% of all 79575 live births at PMH during the study period have congenital CMV infection (n = 796). Therefore, universal hearing screening alone identified only a minority of CMV-infected neonates (n = 19).


   CONCLUSIONS
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
REFERENCES
 
A selective CMV screening program targeting only newborns who do not pass the hearing test would identify some infants with congenital infection, but the majority of CMV-infected newborns would be missed. Those infants would not receive necessary audiologic rescreening to monitor for the development of late-onset hearing deficits that could affect language acquisition and educational achievement. Identification of all neonates who have congenital CMV infection and are at risk for hearing loss both during the newborn period and throughout childhood requires universal CMV screening at birth.29,30 Feasible, cost-effective methods to make this happen are urgently needed.12,25,31


   FOOTNOTES
 
Accepted Sep 19, 2007.

Address correspondence to Elizabeth K. Stehel, MD, Departments of Pediatrics, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-9063. E-mail: elizabeth.stehel{at}utsouthwestern.edu

The authors have indicated they have no financial relationships relevant to this article to disclose.


What's Known on This Subject

Congenital CMV infection is a known cause of hearing impairment in newborns.

 

What This Study Adds

This study adds the frequency of congenital CMV infection among newborns who did not pass hearing screening tests and how often abnormal hearing screening results were the only manifestation of congenital CMV infection.

 


   REFERENCES
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSIONS
 REFERENCES
 

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PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics

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