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Purpose Congenital cytomegalovirus (cCMV) is the most common congenital infection worldwide and a leading environmental cause of pediatric hearing loss (HL). The objective of this study was to evaluate audiologists and speech-language pathologists (SLPs) on awareness and knowledge of cCMV. Method A multiple-choice survey assessing awareness, knowledge, and practice patterns was sent electronically to audiologists and SLPs of the American Speech-Language-Hearing Association. Results were compared between audiologists and SLPs and within stratified groups of audiologists. Data were collected, and descriptive analysis was performed. Results Ninety-four audiologists and 317 SLPs responded. Most audiologists were somewhat or very familiar with cCMV (85.9%), while only 26% of SLPs responded that they were at least somewhat familiar with cCMV ( p < .0001). When comparing audiologists' and SLPs' knowledge of symptoms, transmission, and diagnostic age for cCMV, audiologists had higher scores in all categories ( p < .0001). Audiologists were then stratified into subgroups to evaluate the association of the given subgroup with their overall knowledge. The more advanced audiology training, the more knowledgeable the respondent was regarding HL progression ( p = .002). Audiologists who were more familiar with cCMV scored better in most categories compared to those reporting somewhat or less familiar; these findings were only significant for knowledge of symptoms ( p < .0001). Audiologists who were sometimes or frequently evaluating children less than 5 years of age had a better understanding of HL presentation among cCMV patients than those who rarely saw this patient population. Those who were in practice for < 20 years frequently knew the time-sensitive age of diagnosis than respondents in practice longer. Conclusions As a leading environmental cause of pediatric HL, cCMV is frequently encountered by audiologists and SLPs. This study highlights knowledge gaps and areas where targeted education is needed for both groups.

Background Intraoperative auditory brainstem response (ioABR) testing under general anesthesia is commonly performed on children when sleep-deprived ABR and behavioral testing are not reliable or feasible. Several studies have reported potential confounding results when tube insertion is combined with ABR testing. Purpose This article evaluates whether a temporary threshold shift (TTS) occurs following placement of tympanostomy tubes (TTs) in children who undergo ioABR testing. Research Design A case–control prospective study. Patients scheduled for combined TT and ioABR procedures were enrolled into this study. Study Sample Twenty children (38 ears), ranging in age from 6 months to 10.5 years, were enrolled. Data Collection and Analysis ABR thresholds for tone bursts with center frequencies of 2 and 4 kHz were compared before and after tube insertion. The indication for surgery, comorbidities, and status of the middle ear were also recorded. A paired t-test was used to determine statistical significance. Results Data collection did not necessarily indicate suctioning and tube placement were causing a TTS; however, fluid present in the middle ear space prior to TT placement appeared to influence results. Although a paired t-test did not show statistically significant differences in ABR thresholds between groups of individuals with and without fluid and before and after tube placement, 50% of patients with mucoid fluid (two out of four patients) were noted to have 10 dB or greater worsening in ABR thresholds in two out of six ears. Twenty-nine percent of patients with serous fluid (two out of seven patients) were noted to have at least a 10 dB worsening in ABR threshold in 2 out of 10 ears. Further testing is needed to confirm these trends. Conclusion This pilot study indicates that children with mucoid or serous fluid may experience worse ABR thresholds following TT insertion. ioABR testing immediately after TT tube placement and in the presence of middle ear fluid should be interpreted with caution. Additional studies with a larger sample size are needed to confirm these results.

Background In 2013, Utah enacted legislation requiring that infants failing newborn hearing screening be tested for cytomegalovirus infection. As a result, cytomegalovirus-infected infants are being identified because of hearing deficits. The neuroimaging findings in this population have not been characterized. Methods Retrospective medical record review was used to identify patients seen at the University of Utah and Primary Children’s Hospitals in Salt Lake City, Utah, who failed newborn hearing screening. A cohort of patients with congenital cytomegalovirus infection, brain magnetic resonance imaging (MRI), and sedated auditory brainstem response testing was studied. Results Seventeen patients were identified; 11 (65%) were female. Confirmatory auditory brainstem response testing, performed at a median age 29 days, showed profound hearing loss in 8 (47%) subjects, severe loss in two (12%), moderate loss in two (12%), and mild loss in three (18%); two (12%) subjects had normal hearing. The diagnosis of cytomegalovirus infection was made at a median age 23 days. Brain imaging was performed at a median age 65 days. Ten (59%) subjects had one or more neuroimaging abnormality. White matter lesions were found in eight (47%) subjects, cysts in three (18%), and stroke in two (12%). Polymicrogyria was identified in two (12%) subjects. Seven (41%) subjects had normal brain MRIs. Conclusions These results indicate that most infants whose cytomegalovirus infections were identified after failing newborn hearing screening had abnormal brain MRIs. Our results suggest that brain MRIs should be considered in infants with congenital cytomegalovirus infections who are identified through hearing screening programs.

Objective This study aimed to determine the outcomes from an expanded targeted early congenital cytomegalovirus (cCMV) testing program. Study Design A retrospective analysis of data was collected from June 2016 to April 2018 of patients who underwent expanded targeted early cCMV testing during the peri-implementation phase. Information regarding patient presentation, test type/result, and audiologic outcomes were collected. Chi-square and two-sample t-tests were performed. Results A total of 754 patients underwent cCMV testing; during that period there were 56,947 births at 20 different hospitals. Reasons for completing cCMV testing included the following: (1) failed hearing screening (35.8%), (2) intrauterine growth restriction (IUGR) or small for gestational age (SGA) (29.1%), (3) sepsis (10.7%), (4) other/unknown (8.7%), (5) elevated liver enzymes or bilirubin (5.1%), (6) thrombocytopenia (5.1%), (7) central nervous system abnormalities (3.3%), and (8) mother with suspected cCMV infection (2.2%). The most frequent type of cCMV test performed was urine polymerase chain reaction (75.8%). A total of 21 (2.8%) patients tested positive for cCMV, of which 12 (57%) were symptomatic. This value represents a prevalence of 36.9 cCMV cases and 21.1 symptomatic cCMV cases diagnosed per 100,000 live births. Criteria most commonly associated with a positive testing were failed hearing screening (33.3%), IUGR/SGA (28.6%), and a mother with suspected cCMV infection (19.0%). Conclusion Implementation of an expanded targeted early CMV testing program has the potential to identify symptomatic cCMV infants who would not be identified otherwise.

OBJECTIVES. The goal of the study was to determine whether reactive oxygen species (ROS) mediates cytomegalovirus (CMV)–induced labyrinthitis. STUDY DESIGN. Murine model of CMV infection. SETTING. University of Utah laboratory. SUBJECTS AND METHODS. Nrf2 knockout mice were inoculated with murine CMV. Auditory brainstem response (ABR) and distortion product otoacoustic emissions (DPOAEs) were then performed on these and uninfected controls. BALB/c mice were inoculated with murine CMV to determine whether a marker for ROS production, dihydroethidium (DHE), is expressed 7 days after inoculation. Finally, 2 antioxidants—D-methionine and ACE-Mg (vitamins A, C, and E with magnesium)—were administered 1 hour before and after infection in inoculated mice for 14 days. Temporal bones were harvested at postnatal day 10 for DHE detection. ABR and DPOAE testing was done at postnatal day 30. Scanning electron microscopy was also performed at postnatal day 30 to evaluate outer hair cell integrity. RESULTS. Nrf2-infected mice had worse hearing than uninfected mice (P < .001). A statistically significant increase in DHE fluorescence was detected in BALB/c-infected mice as compared with uninfected mice 7 days after inoculation. D-methionine- and ACE-Mg-treated mice demonstrated an attenuation of the DHE fluorescence and a significant improvement in ABR and DPOAE thresholds when compared with untreated infected controls (P

OBJECTIVE. To describe the progression of sensorineural hearing loss (SNHL) in the better- and poorer-hearing ears in children with asymptomatic congenital cytomegalovirus (CMV) infection with isolated SNHL. STUDY DESIGN. Longitudinal prospective cohort study. SETTING. Tertiary medical center. SUBJECTS AND METHODS. We analyzed hearing thresholds of the better- and poorer-hearing ears of 16 CMV-infected patients with isolated congenital/early-onset or delayed-onset SNHL identified through hospital-based CMV screening of >30,000 newborns from 1982 to 1992. RESULTS. By 12 months of age, 4 of 7 patients with congenital/early-onset SNHL developed worsening thresholds in the poorer-hearing ear, and 1 had an improvement in the better-hearing ear. By 18 years of age, all 7 patients had worsening thresholds in the poorer-hearing ear and 3 patients had worsening thresholds in the better-hearing ear. Hearing loss first worsened at a mean age of 2 and 6 years in the poorer-and better-hearing ears, respectively. Nine patients were diagnosed with delayed-onset SNHL (mean age of 9 years vs 12 years for the poorer- and better-hearing ears), 6 of whom had worsening thresholds in the poorer-hearing ear and 1 in both ears. CONCLUSION. In most children with congenital CMV infection and isolated SNHL, the poorer-hearing ear worsened earlier and more precipitously than the better-hearing ear. This study suggests that monitoring individual hearing thresholds in both ears is important for appropriate interventions and future evaluation of efficacy of antiviral treatment.

Introduction There is increasing concern regarding the risks associated with the use of general anesthesia in pediatric patients. Many otolaryngologic procedures performed under general anesthesia can also be performed in clinic. We hypothesize that anxiolytics can aid in performing common procedures in clinic thus avoiding the need to undergo general anesthesia in the OR. Methods We performed a retrospective review of patients undergoing inoffice procedures with anxiolytics in our pediatric otolaryngology outpatient clinic between February 2013 and January 2017. Charts were reviewed for age, past medical history, procedure type/duration, and outcome. These results were then compared to a cohort undergoing similar procedures in the OR. Results A total of 34 patients underwent an in-office procedure with an anxiolytic. The success rate was 97% (33/34). The average age was 6.2 years. Six children (17%) had a known history of chromosomal abnormalities and 2 children (6%) had autism. The four most common procedures performed were cerumen impaction removal (8), flexible laryngoscopy (6), ear canal foreign body removal (5), and septal cautery (4). Performing similar procedures in the OR resulted in an average additional cost of $822. Conclusions Performing procedures with anxiolytics in a pediatric otolaryngology clinic is safe, expeditious, and cost-effective. Anxiolytics can provide an effective alternative to general anesthesia.

OBJECTIVES: Congenital human cytomegalovirus (cCMV) is a leading cause of pediatric hearing loss. Recent literature has suggested that valganciclovir (VGCV) therapy can improve hearing outcomes. The objective of this study was to evaluate the long-term hearing outcomes among symptomatic CMV patients treated with VGCV. METHODS: A retrospective chart review of symptomatic CMV patients treated with VGCV was completed. The primary endpoint was the change in best ear hearing scores prior to treatment and after follow-up audiograms. A paired-sample t-test was used to evaluate the data. RESULTS: A total of 16 children were included in the study and participants were followed for an average of 3.2 years. There was a measurable worsening, but not a statistically significant change in the best ear hearing scores, where the mean change was 11.9dB (p-value=0.070). However, 14/16 patients (87.5%, p-value

Hypothesis The pose (i.e., position and orientation) of a guinea-pig cochlea can be accurately estimated using externally observable features, without requiring computed-tomography (CT) scans. Background Guinea pigs are frequently used in otologic research as animal models of cochlear-implant surgery. In robot-assisted surgical insertion of cochlear-implant electrode arrays, knowing the cochlea pose is required. A preoperative CT scan of the guinea-pig anatomy can be labeled and registered to the surgical system, however, this process can be expensive and time consuming. Methods Anatomical features from both sides of 11 guinea-pig CT scans were labeled and registered, forming sets. Using a groupwise point-set registration algorithm, errors in cochlea position and modiolar-axis orientation were estimated for 11 iterations of registration where each feature set was used as a hold-out set containing a reduced number of features that could all be touched by a motion-tracking probe intraoperatively. The method was validated on 2000 simulated guinea-pig cochleae and six physical guinea-pig-skull cochleae. Results Validation on simulated cochleae resulted in cochlea-position estimates with a maximum error of 0.43 mm and modiolar-axis orientation estimates with a maximum error of 8.1 degrees for 96.7% of cochleae. Physical validation resulted in cochlea-position estimates with a maximum error of 0.80 mm and modiolar-axis orientation estimates with a maximum error of 12.4 degrees. Conclusions This work enables researchers conducting robot-assisted surgical insertions of cochlear-implant electrode arrays using a guinea-pig animal model to estimate the pose of a guinea-pig cochlea by locating six externally observable features on the guinea pig, without the need for CT scans.

Compare outcomes between a microscopic and endoscopic technique for anterior tympanic membrane (TM) perforation.Results of microscopic overlay (MT) and endoscopic tympanoplasty (ET) for management of anterior TM perforations from a single surgeon.There were 28 patients in the MT group and 35 in the ET group. The mean age was 7.1 years and 10.9 years (p 0.001) MT and ET groups respectively. There was no statistical differences in perforation location (p = 0.1), etiology (p = 0.52) or size (p = 0.1) between both groups. Mean operating time was 119.0 min and 131.0 min in the MT and ET groups respectively (p = 0.23). Follow up was 30.9 months and 9.0 months (p = 0.001) MT and ET respectively. The perforation was successfully closed in 29 patients at 6 weeks in the ET (82.9%) and 25 in the MT (89.3%), p = 0.47. Adjusting for age revealed no significant difference between groups. Long term follow up, resulted in 10 failures (28.6%) and 7 patients (25.0%) in the ET and MT groups respectively, p = 0.75. Adjusting for the follow-up period or age, there was no significant difference between groups. The change in ABG and PTA measures were not statistically different between groups.An anteriorly based ET is a novel technique for management of anterior TM perforations. Results from this pilot study indicate that this ET approach may be an appropriate alternative to MT for difficult to repair anterior perforations. A longer follow-up will be necessary to determine its role in these perforations.

Outer ear infections (OE) affect millions of people annually with significant associated healthcare costs. Incorrect administration or non-compliance with the treatment regimen can lead to infection persistence, recurrence, antibiotic resistance, and in severe cases aggravation to malignant otitis externa. Such issues are particularly pertinent for military personnel, patients in nursing homes, the geriatric population, for patients with head or hand tremors and for those with limited or no access to proper healthcare. With the intent of using traditional material science principles to deconvolute material design while increasing relevance and efficacy, we developed a single application, cold-chain independent thixotropic drug delivery system. This can be easily applied into the ear as a liquid, then gels to deliver effective concentrations of antibiotics against bacterial strains commonly associated with OE. The system maintains thixotropic properties over several stress/no stress cycles, shows negligible swelling and temperature dependence, and does not impact the minimum inhibitory concentration or bactericidal effects of relevant antibiotics. Moreover, the thixogels are biocompatible and are well tolerated in the ear. This drug delivery system can readily translate into a user-friendly product, could improve compliance via a single application by the diagnosing health care provider, is expected to effectively treat OE and minimize the development of antibiotic resistance, infection recurrence or exacerbation.

Objectives To determine whether common otolaryngology procedures generate viable aerosolized virus through a murine cytomegalovirus (mCMV) model for infection. Study Design mCMV model of infection. Setting University of Utah laboratory. Methods Three-day-old BALB/c mice were inoculated with mCMV or saline. Five days later, each mouse underwent drilling, microdebrider, coblation, and electrocautery procedures. Particle size distribution and PM2.5 (particulate matter 100-fold increases in aerosol concentrations over background; only coblation and drilling produce aerosolized viral DNA. The high concentration of aerosols from coblation and electrocautery suggests the need for appropriate safeguards against particle exposure to health care workers. The presence of viral DNA from drilling and coblation procedures warrants the need for appropriate protection against droplet and aerosol exposure.

Hearing loss is the most common congenital defect. With early diagnosis and intervention, we are able to improve speech and language outcomes in this population. In this article, we discuss the implications of the newborn hearing screen, as well as diagnostic interventions, management, and intervention, and the increasing role of congenital cytomegalovirus screening.

Introduction: In this study we aimed to determine surgical outcomes of pediatric patients undergoing surgery with perioperative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnosis. Methods: We examined all patients 18 years old and younger who underwent surgery at a children's hospital and tested positive for SARS-CoV-2 within 1 week before or after their procedure. Age-matched control patients who underwent similar procedures over the past ten years were included in a 3:1 ratio. The primary outcome of our study was 7- and 30-day mortality rates. Secondary outcomes in our study were postoperative pulmonary complications, specifically unexpected ventilation, pneumonia, or acute respiratory distress syndrome. Other outcomes included postoperative hospital stay, ICU admission, and readmission for surgical complications. Results: Our study included 43 procedures performed on 39 patients who tested positive for SARS-CoV-2 and underwent surgery from March 1, 2020 to December 31, 2020. No 7- or 30-day mortality events were observed in any patients. Pulmonary complications were observed in 3 out of 43 (7%) surgeries performed on patients with perioperative SARS-CoV-2 diagnosis, and no pulmonary complications were observed in 124 surgeries performed on patients without SARS-CoV-2 diagnosis (p=.003). SARS-CoV-2 diagnosis did not affect length or occurrence of postoperative hospital stay, ICU admission, and readmission for surgical complications. Abnormal preoperative chest x-ray and preoperative blood pressure were also associated with pulmonary complications in additional analyses (p=.02 and.01, respectively). Conclusion: Our results indicate that pediatric patients undergoing surgery with perioperative SARS-CoV-2 diagnosis may be at increased risk for pulmonary complications.

To determine if Gadolinium-based enhanced Magnetic Resonance Imaging (GdMRI) can be used to predict sensorineural hearing loss (SNHL) in pediatric patients diagnosed with bacterial meningitis.Design: Retrospective chart review.Primary Children's Hospital, Salt Lake City, Utah.and Methods: We studied forty-two pediatric patients diagnosed with bacterial meningitis who underwent brain GdMRI during their index hospital admission and for whom ear specific audiometric data were available (August 2008-July 2018). A pediatric neuroradiologist, blinded to both disease and audiometric data, rated cochlear enhancement of each GdMRI (0-3; none to markedly enhanced).Ear specific MRI scores were statistically significantly related to ear specific hearing outcomes (p 0.01). SNHL occurred in 19 out of 82 ears (12 out of 42 patients; 2 ears were excluded due to pre-existing SNHL in one ear and inability to read the GdMRI on the other ear). Ten of 19 ears (53%) that developed SNHL showed mild/moderate/marked enhancement (MRI score of 1, 2, or 3 respectively). Fifty-three of the 63 unaffected ears (84%) showed no enhancement (MRI score of 0). Ten of 13 (77%) ears that developed severe to profound SNHL showed mild/moderate/marked enhancement. GdMRI was 58% sensitive and 84% specific in predicting which ears would develop SNHL. GdMRI was 77% sensitive and 84% specific in identifying severe to profound SNHL.Our study demonstrates that GdMRI is a promising tool for predicting specifically severe-profound hearing loss in pediatric patients following bacterial meningitis infection.

Congenital cytomegalovirus (cCMV) infection is a major cause of childhood hearing loss and neurodevelopmental delay. Identification of newborns with cCMV infection allows provision of beneficial interventions. However, most infants with cCMV infection have subclinical infection and go undiagnosed. Thus, expanded neonatal CMV testing is increasingly recommended. Saliva is an attractive sample type for CMV testing of newborns, because it is easier to collect than urine and more sensitive for CMV detection than dried blood spots. We evaluated the Alethia CMV assay, a rapid, easy-to-use loop-mediated isothermal amplification method for qualitative detection of CMV DNA in neonatal saliva samples. Saliva swabs were collected prospectively from newborns

Objectives To understand caregiver knowledge of and attitudes toward congenital cytomegalovirus (cCMV) testing in Utah. Study design We surveyed 365 caregivers whose children were being seen in an otolaryngology clinic at a tertiary pediatric hospital about their knowledge of and attitudes toward cCMV and cCMV screening. Descriptive statistics and cluster analysis were used to examine their responses. Results The majority of caregivers were unsure how cCMV was spread, the symptoms of cCMV, and why cCMV screening of infants was important. Most caregivers did not know that cCMV screening was required by law in Utah if an infant is referred after newborn hearing screening. A majority wanted to know if their child had cCMV even if asymptomatic and were willing to pay $20 for cCMV screening. Caregivers of children who had been tested for cCMV were significantly more likely to be strongly in favor of cCMV screening than expected by chance. Caregivers in the highly knowledgeable cluster were more likely to be strongly in favor of cCMV screening. Conclusions Caregivers frequently were unaware of cCMV and its implications. Attitudes toward cCMV screening generally were positive. Education on epidemiology and impact of cCMV may benefit both prevention of infection and attitudes toward screening.

Advanced practice providers (APPs), including nurse practitioners and physician assistants, have been deployed in children's hospital-based academic pediatric otolaryngology practices for many years. However, this relationship in terms of prevalence, roles, financial consequences and satisfaction has not been examined. The objective of this study is to explore how APPs impact healthcare delivery in this setting.Pediatric otolaryngology chiefs of all academic children's hospitals in the US were electronically surveyed about the ways APPs intersected clinically and financially in their respective practice.A total of 29 of 36 children's hospital-based pediatric otolaryngology practices completed the survey, of which 26 practices (90%) utilized APP. There were large variances within the APP practice cohort in faculty size (mean/median/range = 9.4/8.5/3-29); annual patient visits (mean/median = 18,373/17,600); number of practice site (mean/median/range = 4.3/4/2-9) and number of outpatient APP (mean/median/range = 6.3/5/1-30). No factors (faculty size, annual visits and number of practice sites) differentiated between the APP and non-APP practices. Among APP practices, significant correlation (p.00001) was observed between size of APP cohort to faculty size and annual visits. 69% of the practices did not differentiate job functions of nurse practitioners and physician assistants. 85% of the practices utilized APPs in all practice sites and 19% utilized APPs in the operating room. 77% of APPs billed independently and 46% had on-site supervision. The most prevalent APP salary bracket based on 0-5, 6-10 and 11 years of tenure were $76-100K (65%), $100-150K (77%) and $100-150K (86%), respectively. In 46% of the practices, APPs were able to generate enough revenue to cover more than 75% of their salary and 23% of practices generated a profit. 81% of the chiefs ranked the effectiveness of APPs as high (4 and 5) on a 5-point Likert scale.The majority of academic pediatric otolaryngology practices employed APPs. Despite the diversity seen in practice complexity, APP functionality and financial impact, most found the APP model to be beneficial in improving patient care, patient access and faculty productivity.

This case series aims to determine the optimal surgical approach for pediatric laryngeal saccular cysts. A retrospective chart review of patients who underwent surgical treatment for laryngeal saccular cysts was completed; 5 patients were diagnosed and surgically treated. Treatment approaches included aspiration, supraglottoplasty, injection of bleomycin, endoscopic subtotal resection (marsupialization with the laser or endoscopic instrumentation of the cyst), endoscopic extended subtotal excision (subtotal resection plus removal of false vocal fold with lasering or coblation of the inner cyst wall), and transcervical approaches for resection. Based on our outcomes, an endoscopic extended subtotal resection of the cyst will achieve the best outcomes for cysts confined to the larynx or for Type 1 cysts. A transcervical approach for resection of the cyst will achieve the best outcomes for Type 2 cysts that extend into the neck or are extralaryngeal.

Objective To evaluate pediatric otolaryngologists, neurotologists, and otologists on awareness and knowledge of congenital cytomegalovirus (cCMV). Study Design Pilot cross-sectional online survey. Setting Otolaryngology practices. Subjects and Methods An electronic multiple-choice questionnaire was sent email listserv to physician members of the American Society of Pediatric Otolaryngology and American Otological Society. The survey assessed demographics, physician awareness, and practice patterns. Data were collected and analyzed. Results Seventy (14.5%) pediatric otolaryngologists and otologists responded. All responded that they are familiar with cCMV. Most were familiar with symptoms associated with cCMV with the exception of petechia/purpura. Less than 50% knew the incidence/natural history of cCMV-induced hearing loss. Only 63% knew that saliva or urine polymerase chain reaction/culture should be performed prior to 3 weeks of age. Less than half knew the indications for dry blood spot testing, and many incorrectly recommended serologic saliva or urine testing in a child >3 weeks old. Most respondents do not offer any diagnostic testing for cCMV or referral for antiviral therapy for those who may benefit from this treatment. Most either did not know the cCMV screening policy or did not have one at their institution. Conclusion Despite a relatively low overall response rate, this study suggests several knowledge gaps and underutilization of cCMV testing by physicians who frequently encounter pediatric hearing loss. The findings from this pilot study demonstrate the need for further educational directives focused on cCMV to improve knowledge and incorporation of cCMV best practices.

OBJECTIVE To determine whether ganciclovir (GCV) treatment reduces sensorineural hearing loss in cytomegalovirus (CMV)-infected mice. The effects of GCV on viral load, absolute neutrophil count (ANC), and outer hair cell (OHC) integrity were also investigated. METHODS Infected BALB/c mice were inoculated with murine CMV on postnatal day 3. Those treated with GCV received an intraperitoneal injection twice a day for 14 days. Auditory thresholds were assessed using distortion product otoacoustic emission (DPOAE) and auditory brainstem response (ABR) testing 4 weeks after inoculation. Temporal bones were used for determination of viral load by quantitative polymerase chain reaction and hair cell quantification by scanning electron microscopy. ANCs were completed by an automated hematology analyzer, with manual review for confirmation. RESULTS GCV-treated CMV-infected mice had lower ABR (P

Objective Antioxidants have been used as a therapeutic measure for several causes of hearing loss, and this study aims to examine the use of antioxidants in children with congenital cytomegalovirus (cCMV)–related hearing loss. Study Design Case-control study. Setting Academic pediatric hospital. Subjects and Methods A retrospective chart review of pediatric patients with cCMV-related hearing loss treated with and without antioxidants (vitamins A, C, and E and magnesium, known as ACE-Mg) was completed. The primary end point was the mean change in hearing thresholds for the right and left ears after therapy. An evaluation of the mean change in thresholds was evaluated at the following frequencies: 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. A 2-sample t test and multiple linear regression were used to evaluate the data. Results A total of 78 children with cCMV-related hearing loss were included in the study, of whom 10 were treated with antioxidants. The average amount of time in which antioxidants were taken was 387 days. When comparing cases and controls, there was no differences in the mean change of hearing thresholds at each frequency for both the right and left ears ( P > .05). Length of antioxidant therapy and age at which therapy was initiated had no effect on hearing scores ( P > .05). Conclusions Oxidative stress plays a role in the pathogenesis of cCMV-related hearing loss. ACE-Mg is a safe adjuvant therapy for the treatment of hearing loss in children; however, this study demonstrates no hearing-related benefit from ACE-Mg antioxidant therapy.

Objectives To determine whether a canal wall down mastoidectomy can provide long-term benefit for children with aural stenosis. Methods Retrospective case series of children with congenital aural stenosis having undergone a canal wall down mastoidectomy over a twelve-year period at a tertiary children's hospital. Results Data from thirteen children who underwent a total of twenty canal wall down mastoidectomies for aural stenosis were reviewed. The mean age at surgery was 7.1 years (range, 3.3–12.3 years). All patients had genetic syndromes including Trisomy 21 (n = 7), Trisomy 21 and Pierre Robin sequence (n = 1), Angelmann (n = 1), Cri-du-chat (n = 1), Branchio-oto-renal syndrome (n = 1), Spina bifida (n = 1) and Nager syndrome (n = 1). Seven (54%) children underwent bilateral canal wall down mastoidectomies. All thirteen ears that could not be visualized preoperatively had improved ease of office examination following surgery. Only one patient required revision surgery and all canals were patent at the last clinic visit. The mean follow-up was 4.9 years. There were no cases of facial nerve injury or cerebrospinal fluid leak. Conclusion Syndromic children with congenital aural stenosis with poorly pneumatized mastoids may benefit from canal wall down mastoidectomy to improve ease of office examinations.

OBJECTIVES: To describe the clinical presentations and management of detergent pod ingestion at a tertiary children's hospital. STUDY DESIGN: Case series. METHODS: A retrospective chart review of children diagnosed with detergent pod ingestion from June 2010 and March 2015. RESULTS: Nine cases of detergent pod ingestion were included over a 5-year period. The average age was 26.3 months (range, 11-43 months). Eight (89%) of the cases were female. The patients had ingested laundry detergent pods (n = 7) and dishwasher detergent pods (n = 2). The majority of patients (67%) had more than one clinical manifestation from ingestion. Presenting symptoms included emesis (78%), respiratory symptoms (56%), throat pain (22%), drooling (33%), and foaming at the mouth (33%). The management of patients depended on the severity of their symptoms and included admission to an overnight observation unit (n = 5), discharge to home directly from the emergency department (n = 2), and admission to the hospital (n = 2). Two (22%) children underwent esophagogastroduodenoscopy. One child (11%) required intubation from bilateral vocal fold immobility. CONCLUSION: Injuries to the upper aerodigestive tract after detergent ingestion range from mild gastrointestinal symptoms to respiratory compromise. The majority of children improve with observation alone; however, clinicians should maintain a low threshold for endoscopic evaluation in cases of severe symptoms and airway involvement. LEVEL OF EVIDENCE: 4. Laryngoscope, 2016.© 2016 The American Laryngological, Rhinological and Otological Society, Inc. Language: en

Objective To investigate the efficacy, safety, and microbiology of a thermosensitive otic suspension of ciprofloxacin (OTO-201) in children with bilateral middle ear effusion undergoing tympanostomy tube placement. Study Design Two randomized, double-blind, sham-controlled phase 3 trials. Patients were randomized to intratympanic OTO-201 or sham. Setting Children with bilateral middle ear effusion undergoing tympanostomy tube placement. Subjects/Methods Studies evaluated 532 patients (6 months to 17 years old) in a combined analysis of efficacy (treatment failure: presence of otorrhea, otic or systemic antibiotic use, lost to follow-up, missed visits), safety (audiometry, otoscopy, tympanometry), and microbiology. Results There was a lower cumulative proportion of treatment failures in patients receiving OTO-201 vs tympanostomy tubes alone (1) on days 4, 8, 15, and 29; (2) on day 15, primary end point (23.0% vs 45.1%; age-adjusted odds ratio, 0.341; P < .001; reduction in relative risk, 49%); and (3) on day 15, blinded-assessor otorrhea treatment failure (7.0% vs 19.4%; age-adjusted odds ratio, 0.303; P < .001; reduction in relative risk, 64%). Per-protocol and subgroup analyses (baseline demographics, pathogen type, culture status, effusion type, microbiologic response) supported these findings. There were no drug-related serious adverse events; the most frequent treatment-emergent adverse events in both groups were pyrexia, postoperative pain, nasopharyngitis, cough, and upper respiratory tract infection. OTO-201 administration had no evidence of increased tube occlusion and no negative effect on audiometry, tympanometry, or otoscopy. Conclusions Combined analysis of 2 phase 3 trials demonstrated a lower cumulative proportion of treatment failures through day 15 compared with TT alone when OTO-201 was administered intratympanically for otitis media with bilateral middle ear effusion at time of tympanostomy tube placement.

OBJECTIVES: Determine whether a murine model of cytomegalovirus (CMV) and CMV- infected children show evidence of synaptopathy. STUDY DESIGN: Murine model of CMV infection and case series SUBJECTS AND METHODS: C57 BL/6 mice were inoculated with murine-CMV (mCMV). Auditory function was assessed using Auditory Brainstem Response (ABR) and distortion product otoacoustic emission (DPOAE) testing. Temporal bones from mCMV-infected mice were used for both ribbon synapse and hair cell quantification. Four groups of children (non-CMV normal hearing, non-CMV hearing impaired, CMV normal hearing and CMV hearing impaired) underwent ABRs between 2014-2018. The outcomes included raw amplitude, wave I:V amplitude ratio, absolute latency, and interpeak latency. RESULTS: Mice at 8 weeks post mCMV infection had higher ABR and DPOAE (P < 0.05) thresholds and increased outer hair cell loss compared to uninfected mice and mCMV-infected mice at 4- and 6-weeks post infection, indicating progressive hearing loss. A reduction in the wave I amplitude and synaptic counts were noted earlier at 4 weeks in CMV-infected mice (P < 0.05). The human data indicated that the wave I:V amplitude ratio was lower on average in CMV-infected groups when compared to the uninfected cohorts. The wave I:V amplitude ratio for the click and 4k stimuli were not significantly different between the congenital CMV-infected and uninfected children with normal or with hearing loss. CONCLUSION: This study suggests mCMV infection results in a synaptopathy before hair cell damage. Additional studies need to be performed to determine whether this effect is also observed in CMV-infected children. LEVEL OF EVIDENCE: animal studies and basic science- NA; human studies: level 4.

Since 2013, after Utah became the first state to implement hearing targeted early CMV screening, a national debate has been percolating about whether this approach should be introduced nationally. Currently Utah, Iowa, Connecticut, and New York have passed legislation mandating early CMV screening, and over 100 birth hospitals across the United States have voluntarily implemented early CMV screening programs as part of their standard of care. We reviewed the evidence related to this approach and used the Wilson and Jungner (1968) criteria to evaluate this method of screening. Based on these criteria, there is substantial rationale and evidence to support a hearing targeted approach to screen for congenital CMV. Given this evidence, we currently recommend that infants who fail newborn hearing screen should undergo CMV screening.

Objective To determine whether a community engagement approach can provide feedback for implementation of valuable measures to improve the outcome of a clinical trial. Methods Review of the results from a Community Engagement Studio (CE Studio) for the ValEAR trial: an NIH-funded, multi-institutional study designed to research the efficacy of valganciclovir in the treatment of congenital cytomegalovirus (cCMV)-induced hearing loss. Participants were given information about the trial then asked a series of questions to assess their input on the merits or weaknesses affecting their participation in the trial. Results Thirteen parents whose children have congenital CMV infection were recruited for the CE Studio. The overall theme from the responses was a desire to advance the field but a need to clearly understand the risks and benefits of participation. Many requested more educational resources, more printed materials, or greater access to researchers if questions arose. Many welcomed having patient stories and information displayed in a dedicated website or through social media. Conclusion This community engagement approach provided useful feedback from families similar to those expected to be potential enrollees in the CMV ValEAR trial. In response to parental comments, two educational videos were created: one on the general topic of cCMV and the other specific to the CMV ValEAR trial. Researchers who wish to optimize their clinical trial's success should consider incorporating a CE Studio into their study design.

To compare the efficacy, safety, and cost of incision and drainage (ID) for pediatric patients with peritonsillar abscesses (PTAs) under conscious sedation (CS) versus unsedated (awake) and general anesthesia (GA).Case series with chart review.Tertiary pediatric hospital.Records for all pediatric patients (18 years) treated for PTAs in the emergency department from 2005 to 2015 were reviewed and stratified into awake, CS, and GA groups for comparison. The primary outcome measure was procedure tolerance, with secondary measures including return to the emergency department within 15 days, complications, and facility costs associated with treatment.A total of 188 patients were identified. The median age was 14 years (interquartile range, 9-16). Awake drainage with injected local anesthetic was used in 115 children; 62 underwent CS; and 11 underwent GA. Over 92% of the children tolerated ID regardless of anesthesia, with no difference among groups ( P = .60). None of those who underwent ID via CS returned to the emergency department within 15 days of the procedure, as compared with 5.2% for the awake group and 9.1% for the GA group ( P = .06). None in the GA or awake group had a complication associated with the procedure, as opposed to 9.6% in the CS group ( P = .02). Complications included apnea and dental trauma (2 children each) and transient hypotension and desaturation (1 each). Cost was highest in the GA group and lowest for the awake group ( P.0001).CS for PTA ID is a viable treatment option with tolerance and success similar to that of the awake and GA groups. Complications were observed for those who underwent CS, but they were manageable.

Some forms of sensorineural hearing loss involve damage or degenerative changes to the stria vascularis and/or other vascular structures in the cochlea. In animal models, many methods for anatomical assessment of cochlear vasculature exist, each with advantages and limitations. One methodology, corrosion casting, has proved useful in some species, however in the mouse model this technique is difficult to achieve because digestion of non vascular tissue results in collapse of the delicate cast specimen. We have developed a partial corrosion cast method that allows visualization of vasculature along much of the cochlear length but maintains some structural integrity of the specimen. We provide a detailed step-by-step description of this novel technique. We give some illustrative examples of the use of the method in mouse models of presbycusis and cytomegalovirus (CMV) infection.

Objectives In this study, we estimate an ex ante cost–benefit analysis of a Utah law directed at improving early cytomegalovirus (CMV) detection. Study design We use a differential cost of treatment analysis for publicly insured CMV-infected infants detected by a statewide hearing-directed CMV screening program. Methods Utah government administrative data and multi-hospital accounting data are used to estimate and compare costs and benefits for the Utah infant population. Results If antiviral treatment succeeds in mitigating hearing loss for one infant per year, the public savings will offset the public costs incurred by screening and treatment. If antiviral treatment is not successful, the program represents a net cost, but may still have non-monetary benefits such as accelerated achievement of diagnostic milestones. Conclusions The CMV education and treatment program costs are modest and show potential for significant cost savings.

Objectives/Hypothesis Assess the role of combined antimicrobial and surgical therapy for difficult-to-treat nontuberculous mycobacteria (NTM) lesions of the head and neck in children. Study Design Retrospective cohort. Methods Retrospective review of pediatric head and neck NTM lesions at a tertiary children's hospital from 1999 to 2012. Results Seventy-one children were diagnosed with NTM lesions. Age of presentation ranged between 7 and 204 months of age. Most patients (62%) had multiple lesions. Treatments included incision and drainage, curettage, antibiotics, excision, and any combination of surgery and antibiotics. Upon initial presentation, the most common treatment was surgical excision alone (n = 34) with a high complication rate (50%). In 18 cases, patients were initially treated with a combination of antibiotics and surgical excision due to the extent or location of the lesion(s). Complication rate in these patients was also high (67%). The most common complications in surgically excised NTM lesions included temporary or persistent facial nerve dysfunction (24.6%), poor wound healing/scarring (10.8%), and Frey's syndrome (6.2%). Conclusions Surgical excision with or without medical therapy for NTM cervicofacial lymphadenitis in high-risk regions commonly resulted in marginal mandibular nerve dysfunction (24.6%). Postoperative facial nerve weakness generally resolved within a year. High rates of complications and a lack of proven best approaches suggest tailoring the approach to address the potential risks in that particular patient based on location and severity. Level of Evidence 4 Laryngoscope, 2015

Objective Determine which risk factors in children with recurrent croup warrant bronchoscopic evaluation. Design Retrospective cohort study. Setting Tertiary paediatric hospital. Participants Children with recurrent croup who underwent a rigid bronchoscopy between 2001 and 2013. Main outcome measures Bronchoscopy findings, classified as normal, mildly abnormal or significantly abnormal. Results Two hundred and thirty-five children underwent a rigid bronchoscopy and 110 underwent a flexible oesophagoscopy. One hundred and forty-five children (61.7%) had a mildly abnormal exam, and 27 children (11.5%) had significant findings that required a surgical intervention or grade 2 or greater subglottic stenosis. The significantly abnormal group included 4 children with laryngomalacia, 2 with a subglottic cyst, 8 with grade 2 or 3 subglottic stenosis and 13 children who underwent a surgical procedure for subglottic stenosis. Sixty-seven children had a preoperative diagnosis of asthma, 62 were atopic and 78 had symptoms of gastro-oesophageal reflux. Oesophagoscopy was diagnostic of gastro-oesophageal reflux in 19 of 110 cases, and 106 children (45.1%) had bronchoscopic findings suggestive of GERD. Eight children had eosinophilic oesophagitis. After multivariate analysis, significantly abnormal bronchoscopy was significantly associated with chronic cough (P = 0.02), have a previous intubation (P = 0.002) or be younger than 3 years old (P = 0.01). Conclusion Significant findings on bronchoscopy that warranted further surgical intervention were uncommon in this cohort. Nearly half of the patients had evidence of gastro-oesophageal reflux. In patients without risk factors for significant abnormalities, empiric medical management may be beneficial prior to endoscopy.

Objective To review our experience treating hypopharyngeal branchial anomalies utilizing an open transcervical approach that: (1) includes recurrent laryngeal nerve (RLN) monitoring and identification if needed; (2) resection of tract if present; and (3) a superiorly based sternothyroid muscle flap for closure. Methods A retrospective chart review was performed to identify all patients at a tertiary level children's hospital with branchial anomalies from 2005 to 2014. The clinical presentation, evaluation, treatment and outcome were analyzed for those patients with hypopharyngeal branchial anomalies. Results Forty-seven patients who underwent excision of branchial anomalies with a known origin were identified. Thirteen patients had hypopharyngeal branchial anomalies. Six of these patients were treated by the authors of this study and are the focus of this analysis. All six underwent an open transcervical procedure with a sternothyroid muscle flap closure of a piriform sinus opening over a nine year period. Definitive surgery included a microlaryngoscopy and an open transcervical approach to close a fistula between the piriform sinus and neck with recurrent laryngeal nerve monitoring or dissection. A superiorly based sternothyroid muscle flap was used to close the sinus opening. There were no recurrences, recurrent laryngeal nerve injuries or other complications from these procedures. Conclusions This study supports complete surgical extirpation of the fistula tract using an open cervical approach, recurrent laryngeal nerve monitoring or identification, and rotational muscle flap closure to treat patients with hypopharyngeal branchial anomalies.

Objectives Determine whether the outcome of tympanoplasty in preschool children is different from that of older children. Study design Retrospective case series. Methods Retrospective review of children having undergone a primary tympanoplasty by 4 surgeons for a tympanic membrane perforation between 2002 and 2013. Results Data from 50 children age 2–4, 130 children age 5–7 and 105 children age 8–13 years old were reviewed. Median follow-up was 7.5 months. On crude analysis, the incidence of anatomical success was not significantly different between the different age groups (p = 0.38), the success rate was respectively 69.4%, 68.5% and 79.1% with an overall rate of 72.5%. 5.9% of all children required later insertion of tympanostomy tubes, 10.2% in preschool children. The post-operative audiology results were similar for all groups with a mean improvement of 9 dB in the air-bone gap. When limiting the analysis to the 155 children having at least 6 months of follow-up, the rate of success was respectively 50.0%, 60.8% and 74.0% (p = 0.10). After multivariate analysis controlling for the effect of surgeon, approach and etiology, the odds ratio of perforation was respectively 5.48, 2.27 and 1.00 for the different age groups. Conclusion Children younger than 4 years of age have the worst outcome after tympanoplasty. It remains uncertain whether the benefits of hearing improvement and quality of life may outweigh that of a high rate of a residual, usually smaller, perforation. Prospective studies are needed to confirm these results and delineate the patient characteristics and technique most likely to lead to successful results.

Objective Optimize the diagnosis of pediatric Sjogren's syndrome in children who present with parotitis. Methods Twenty children presented to a pediatric otolaryngology or rheumatology clinic with recurrent parotitis. Presenting symptoms, serologies, sialendoscopy findings, and minor salivary gland biopsy pathology results were reviewed. Results Twenty patients aged 3–17 years presented with recurrent parotitis. Ten percent of this cohort met the American-European Consensus Group adult diagnostic criteria for Sjogren's syndrome. Forty percent of this cohort met diagnosis of Sjogren's syndrome when utilizing Bartunkova's proposed pediatric criteria for diagnosis of Sjogren's syndrome. Conclusion Sjogren's syndrome is surprisingly common in pediatric patients who present with recurrent parotitis. Otolaryngologists who treat pediatric parotitis should have a high index of suspicion for Sjogren's syndrome. Level of Evidence 4.

Objectives/Hypothesis To determine the feasibility and cost effectiveness of incorporating cytomegalovirus (CMV) testing to determine the etiology of pediatric hearing loss. Study Design Retrospective study of children presenting with sensorineural hearing loss (SNHL) at one institution from 2008 to 2013. Methods Children aged 3 years or younger who presented to the senior author (A.P.) between May 2008 and September 2013 with confirmed SNHL were evaluated. These children underwent a sequential diagnostic paradigm that incorporated CMV testing if no obvious etiology could be determined from the history or physical examination. Results One hundred eleven children with SNHL were evaluated between 2008 and 2013. Eighty-three children underwent CMV testing, imaging, and a genetic evaluation. Those with confirmed or probable CMV-induced SNHL made up 30% of all children tested (n = 25), the largest group identified. CMV screening had the lowest cost compared to genetic testing or imaging for all types of hearing loss, except for those with auditory neuropathy spectrum disorder. Conclusion We present the first sequential diagnostic paradigm utilizing CMV testing for children presenting with SNHL. The relatively high incidence of CMV-induced SNHL, the low cost for this assay, and the indirect benefits from early diagnosis support the role of early CMV testing for these patients. Level of Evidence 4. Laryngoscope, 124:2624–2629, 2014

To (1) identify the major expenses for same-day adenotonsillectomy (TA) and the costs for postoperative complication encounters in a children's hospital and (2) compare differences for variations in costs by surgeon.Observational cohort study.Tertiary children's hospital.A standardized activity-based hospital accounting system was used to determine total hospital costs per encounter (not including professional fees for surgeons or anesthetists) for TA cases at a tertiary children's hospital from 2007 to 2012. Hospital costs were subdivided into categories, including operating room (OR), OR supplies, postanesthesia care unit (PACU), same-day services (SDS), anesthesia, pharmacy, and other. Costs for postoperative complication encounters were included to identify a mean total cost per case per surgeon.The study cohort included 4824 TAs performed by 14 different surgeons. The mean cost per TA was $1506 (95% confidence interval, $1492-$1519, with a range of $1156-$1828 for the lowest and highest cost per case per surgeon; P.01). Including the cost for postoperative complications, the mean cost increased to $1599 ($1570-$1629). The largest cost categories included OR (31.9%), SDS (28.1%), and OR supplies (15.6%).A large portion of TA expenses are due to OR and supply costs. Significant differences in costs between surgeons for outpatient TA were identified. Studies to understand the reasons for this variation and the impact on outcomes are needed. If this variation does not affect patient outcomes, then reducing this variation may improve health care value by limiting waste.

BACKGROUND AND OBJECTIVES:Cytomegalovirus (CMV) is the most common congenital infection and nongenetic cause of congenital sensorineural hearing loss in the United States. Utah was the first state to pass legislation mandating CMV screening for newborns who fail newborn hearing screening (NBHS). The study objective was to present outcomes of hearing-targeted CMV screening and determine factors predicting CMV screening.METHODS:We used Utah Department of Health HiTrack and Vital Records databases to examine CMV screening from 509 infants who failed NBHS in the 24 months after implementation of the Utah legislation. Multivariate logistic regression analyses were conducted to identify predictors of compliance with CMV screening and diagnostic hearing evaluation.RESULTS:Sixty-two percent of infants who never passed hearing screening underwent CMV screening. Fourteen of 234 infants tested within 21 days were CMV positive; 6 (42.9%) had hearing loss. Seventy-seven percent of eligible infants completed a diagnostic hearing evaluation within 90 days of birth. Compliance with CMV screening was associated with sociodemographic factors, time since the law was enacted, and NBHS protocol. Infants born after the legislation showed greater odds of achieving timely diagnostic hearing evaluation than infants born before the law.CONCLUSIONS:Incorporating CMV screening into an established NBHS program is a viable option for the identification of CMV in infants failing NBHS. The addition of CMV testing can help a NBHS program attain timely audiological diagnostics within 90 days, an important early hearing detection and intervention milestone.

Importance Congenital cytomegalovirus (cCMV) infection is a major cause of childhood deafness. Most cCMV infections are not diagnosed without newborn screening, resulting in missed opportunities for directed care. Objective To estimate the cost-effectiveness of universal and targeted newborn cCMV screening programs compared with no cCMV screening. Design, Setting, and Participants Models were constructed using rates and outcomes from prospective cohort studies of newborn cCMV screening in US postpartum care and early hearing programs. Costs of laboratory testing, treatment, and hearing loss were drawn from Medicaid data and published estimates. The benefits of cCMV screening were assumed to come from antiviral therapy for affected newborns to reduce hearing loss and from earlier identification of hearing loss with postnatal onset. Analyses were performed from July 2014 to March 2016. Interventions Models compared universal or targeted cCMV screening of newborns with a failed hearing screen, with standard care for cCMV infection. Main Outcomes and Measures The incremental costs of identifying 1 cCMV infection, identifying 1 case of cCMV-related hearing loss, and preventing 1 cochlear implant; the incremental reduction in cases of severe to profound hearing loss; and the differences in costs per infant screened by universal or targeted strategies under different assumptions about the effectiveness of antiviral treatment. Results Among all infants born in the United States, identification of 1 case of cCMV infection by universal screening was estimated to cost $2000 to $10 000; by targeted screening, $566 to $2832. The cost of identifying 1 case of hearing loss due to cCMV was as little as $27 460 by universal screening or $975 by targeted screening. Assuming a modest benefit of antiviral treatment, screening programs were estimated to reduce severe to profound hearing loss by 4.2% to 13% and result in direct costs of $10.86 per newborn screened. However, savings of up to $37.97 per newborn screened were estimated when costs related to functionality were included. Conclusions and Relevance Newborn screening for cCMV infection appears to be cost-effective under a wide range of assumptions. Universal screening offers larger net savings and the greatest opportunity to provide directed care. Targeted screening also appears to be cost-effective and requires testing for fewer newborns. These findings suggest that implementation of newborn cCMV screening programs is warranted.

Otorrhea after tympanostomy tube placement (TTP) in children is common. Although not approved by the US Food and Drug Administration, antibiotic ear drops are routinely used intraoperatively and prescribed for multidose, multiday postoperative administration by caregivers.To investigate the safety and efficacy of a single-dose intratympanic, intraoperative, thermosensitive, otic suspension of ciprofloxacin (OTO-201) in children requiring TTP.Two identically designed, prospective, double-blind, sham-controlled, multicenter phase 3 randomized clinical trials included 532 patients aged 6 months to 17 years with middle ear effusions. Patients with confirmed bilateral effusions on the day of TTP were randomized to TTP alone or to TTP with OTO-201 injection. Children underwent a 28-day observation period. Data were collected from November 14, 2013, to June 3, 2014. Final follow-up was completed on June 16, 2014, and intent-to-treat data were analyzed from June 10 to August 27, 2014.Efficacy was assessed as treatment failure, including the presence of otorrhea, use of otic or systemic antibiotics, loss to follow-up, or missed visits. Safety was assessed for serious adverse events and treatment-emergent adverse events using audiometry, otoscopy, and tympanometry.Among the 532 patients included in the trials, 175 were randomized to TTP only and 357 to OTO-201 treatment (304 boys [57.1%]; 228 girls [42.9%]; mean [SD] age, 2.4 [2.1]). At day 15, the cumulative proportion of treatment failures (primary end point) was 24.6% (44 of 179 patients) in trial 1 and 21.3% (38 of 178 patients) in trial 2 in the OTO-201 groups vs 44.8% (39 of 87 patients) in trial 1 and 45.5% (40 of 88 patients) in trial 2 in the TTP-alone groups. At day 15 otorrhea-only treatment failures in trial 1 included 21 of 179 (11.7%) in the OTO-201 group vs 22 of 87 (25.3%) in the TTP-only group; in trial 2, 17 of 178 (9.6%) in the OTO-201 group vs 29 of 88 (33.0%) in the TTP-only group. The odds of otorrhea-only failure were significantly reduced in the OTO-201 groups compared with the TTP-only groups in both trials (age-adjusted odds ratios, 0.38 [95% CI, 0.19-0.75] and 0.19 [95% CI, 0.09-0.38]; P .001 for both trials, post hoc analysis). No drug-related serious adverse events were seen, and most adverse events were mild or moderate. No evidence of increased tube occlusion and no negative effect on results of audiometry, tympanometry, or otoscopy were noted with OTO-201 administration.Two large phase 3 randomized clinical trials demonstrate the safety and efficacy of a single intraoperative administration of OTO-201 for middle ear effusion at the time of TTP.clinicaltrials.gov Identifiers: NCT01949142 and NCT01949155.

Determine clinical signs or symptoms associated with a more complicated clinical course in patients with retropharyngeal abscesses (RPAs).Retrospective chart review at a tertiary care level Children's hospital. Main Outcome Measures Age, presenting signs and symptoms, laboratory tests, imaging results, antibiotic therapy, surgical approach, pathogens isolated, and duration of hospitalization were evaluated to determine any factors associated with a more complicated clinical course (CCC).Fifteen of one hundred thirty pediatric patients with RPA were identified with a complicated clinical course (CCC). Eight of the fifteen required more than one procedure before the abscess resolved. Patients with multiple abscess sites had a statistically significantly greater chance of requiring multiple procedures to clear the infections (p0.001). Another seven presented with airway obstruction requiring an admission into the Pediatric Intensive Care (PICU) and/or intubation. All the patients requiring admission to the PICU presented with signs or symptoms of airway obstruction compared to ten of the one hundred fifteen patients (8.7%) with a smooth clinical course (SCC) (p0.001). Five patients from the CCC group required a bronchoscopy to secure the airway; seven patients required intubation following incision and drainage of the abscess for an average of 5+/-3 days. There was no statistically significant difference between the two groups with respect to pathogens isolated, or antibiotics used.Our study suggests that patients with a CCC are more likely to present with airway obstruction or multiple abscess sites than patients with SCC.

Objectives The objective of this study is to examine the correlation between enlarged vestibular aqueduct (EVA) anomaly and other inner ear anomalies such as cochlear dysplasia, vestibulocochlear dysplasia and modiolar hypoplasia. Methods Retrospective chart review, with institutional review board approval, of patients with EVA who received treatment at Primary Children's Medical Center or University Hospital at the University of Utah, between 1997 and 2006. Review of radiographs was done to evaluate for the presence of EVA and other inner ear anomalies. Results Twenty patients (40 ears) were included in the study, 17 patients had bilateral EVA and three patients had unilateral EVA. There were 10 females and 10 males. The average age of all patients at the time of initial diagnosis was 1.7 years (0–6 years). Thirty-seven ears were shown to have EVA (92.5%). Of those ears with EVA, 29 (78.4%) had one or more inner ear anomalies. Twenty-three (62.2%) ears had cochlear dysplasia, six (16.2%) had vestibulocochlear dysplasia, and 18 (48.7%) had modiolar hypoplasia. Conclusions Using small field of view, thin section CT and/or MR imaging, cochleovestibular abnormalities are commonly identified in association with EVA.

Objectives/Hypothesis: To determine the incidence of left vocal fold paralysis (LVFP) in premature infants who undergo patent ductus arteriosus (PDA) ligation. Study Design: Prospective cohort. Methods: The study was carried out in the newborn intensive care unit (NICU) of a tertiary academic medical center. Eighty-six premature newborns who underwent ligation of a PDA were examined postextubation with fiberoptic laryngoscopy to assess vocal fold mobility, regardless of laryngeal symptom status. Results: Fourteen infants (16%) had LVFP. All were

To describe a different surgical approach to treat pediatric orbital floor fractures. We report the case of a 14-year-old boy who underwent a microscope-assisted repair of his orbital floor fracture 6 weeks after his injury. The microscope provided excellent visualization of the entire orbital floor defect and facilitated placement of a polyethylene implant. The repair was achieved without complications, and follow-up examinations demonstrated improvement in patient's enophthalmos and diplopia. We noted significant advantages with a microscope-assisted repair over an endoscopic technique for this condition. The operating microscope allows for two-handed surgery, does not require withdraw of the endoscope for cleaning, and provides depth of field. A larger patient population and longer follow-up are needed to better assess the clinical efficacy of this technique.

Summary Objective To determine whether a subtotal bovie tonsillectomy decreases postoperative pain following adenotonsillectomy. Methods A prospective, randomized, double-blinded clinical trial was undertaken at a University Pediatric Children's Hospital and included 39 otherwise healthy children, aged 2–12 years, undergoing adenotonsillectomy. Patients were randomized to receive either a subtotal or total removal of the tonsils utilizing an electrocautery technique. The main outcome measures included a visual analog scale (VAS) at rest and while eating, time to take 100 cm 3 of fluid, throat, neck, and ear pain, quantity of liquids, activity level and incidence of emesis and retching. Results A repeated measures analysis using a repeated measures ANOVA failed to demonstrate a statistically significant impact with either treatment for VAS at rest or while eating ( p = 0.52 and 0.48, respectively). A repeated measures analysis did not show either procedure significantly affecting throat, neck or ear pain, or liquid quantity. Time to take 100 cm 3 liquids and the incidence of emesis or retching were found not to be statistically significantly different between the treatment groups. Conclusion Subtotal tonsillectomy via an electrocautery technique does not reduce postoperative pain or improve outcome parameters. Subtotal tonsillectomy with this technique is not recommended for this patient population.

Objective Follicular tracheitis (also known as tracheal cobblestoning) is an entity that is poorly described and of unclear significance. The objective of this study was to better define follicular tracheitis and determine the association between the clinical finding of follicular tracheitis on bronchoscopy and objective evidence of gastroesophageal reflux disease. Methods Retrospective chart review of children with recurrent croup having undergone a rigid bronchoscopy and an investigation for gastroesophageal reflux between 2001 and 2013. Results 117 children with recurrent croup children age 6–144 months were included in the study. Follicular tracheitis was noted on 41% of all bronchoscopies. Fifty-nine percent of all children who underwent bronchoscopy were diagnosed with gastroesophageal reflux on at least one investigation. Forty-nine of 117 children underwent a pH probe study, and 51% were found to have evidence of reflux on this study. Nine children were diagnosed with eosinophilic esophagitis. Three patients underwent a biopsy of the follicular tracheitis lesions, which revealed chronic inflammation. There was no evidence of an association between findings of follicular tracheitis and a positive test for gastroesophageal reflux ( p = 0.52) or a positive pH probe study ( p = 0.64). There was no association between follicular tracheitis and subglottic stenosis ( p = 0.33) or an history of asthma and/or atopy ( p = 0.19). Conclusion In children with recurrent croup, follicular tracheitis remains an unspecific finding associated with an inflammatory disorder of unknown etiology.