Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media.

BACKGROUND: Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media. METHODS: We randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period. RESULTS: In our main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group (P = 0.66). Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively. Among secondary outcomes in the main analysis, results were mixed. Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure. Favoring medical management was children's cumulative number of days with otorrhea. Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates. Trial-related adverse events were limited to those included among the secondary outcomes of the trial. CONCLUSIONS: Among children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).

Trichloroacetic acid Alloderm™ Myringoplasty as a novel option for tympanic membrane reconstruction in children.

PURPOSE: A novel "Modified TCA Alloderm™ Myringoplasty" (TCA myringoplasty) technique for reconstruction of uncomplicated chronic tympanic membrane (TM) perforations is described. MATERIALS AND METHODS: Descriptive surgical technique for TCA myringoplasty on 12 total patients from 1/1/2020 to 12/31/2020. 3 patients were excluded for incomplete records. Statistical analysis employed Wilcoxon signed-rank tests. Both structural (pre/post visual inspection and tympanogram) and functional (pre/post pure tone average, PTA) outcome measures are reported. RESULTS: 12 total ears were analyzed from 9 patients. Average age at surgery was 6 (range 3-22). Perforation size ranged from 10 to 60 %. Rate of structural success was 100 %. Functionally, postoperative PTA were significantly decreased from preoperative (mdn(range) = 18.44(13.13-24.38) vs mdn(range) = 11.25(6.25-22.50), p = .008). Only one TM required >1 procedure to achieve closure. CONCLUSIONS: Chronic TM perforations are typically reconstructed via Type I tympanoplasties with temporalis fascia, reserving myringoplasty for favorable perforations (<25 % in size and posterior). Our novel TCA myringoplasty technique has excellent outcomes independent of size and location. We apply a chemical peel concept to a modified myringoplasty technique, obviating incisions and graft harvest. Advantages of Alloderm™ include: 1) a more rigid graft, facilitating manipulation and precise placement; 2) various size and thickness options, especially useful for dimeric tympanic membranes, tympanolysis of adhesions, and bilateral perforations; 3) no donor morbidity and harvest time; 4) autologous tissue preservation. The sole disadvantage of cost is mitigated by reduced operative time and complication management. This study revealed encouraging proof-of-concept preliminary data warranting prospective and sufficiently powered analysis, supporting the technique as a viable alternative to the gold standard.

Initiation of acid suppression therapy for laryngomalacia.

OBJECTIVE: Evidence supporting the use of acid suppression therapy (AST) for laryngomalacia (LM) is limited. The objective of this study was to determine if outpatient-initiated AST for LM was associated with symptom improvement, weight gain, and/or avoidance of surgery. METHODS: A retrospective cohort was reviewed at a tertiary-care children's hospital. Patients were included if they were diagnosed with LM at ≤6 months of age, seen in an outpatient otolaryngology clinic between 2012 and 2018, and started on AST. Primary outcomes were improvement of airway and dysphagia symptoms, weight gain, and need for surgery. Severity was assessed by symptom severity. RESULTS: Of 2693 patients reviewed, 199 met inclusion criteria. Median age of diagnosis was 4 weeks (range: 0-29 weeks). LM was classified as mild/moderate (71.4%) and severe (28.6%) based on symptom severity. Severity on flexible fiberoptic laryngoscopy (FFL) was not associated with clinical severity. Weight percentile, airway symptoms, and dysphagia symptoms improved within the cohort. In total, 26.1% underwent supraglottoplasty (SGP). In multivariate analysis, only severe LM on FFL was predictive of SGP (OR: 7.28, 95%CI: 1.91-27.67, p = .004). CONCLUSION: Clinical symptom severity did not predict response to AST raising the question of utility of AST in LM. Severity of LM based on FFL, not clinical severity, was associated with decision to pursue SGP. Prospective randomized trials are needed to better understand the role of AST in LM. LEVEL OF EVIDENCE: Level 3.

Otitis media prone children with cystic fibrosis: A new normal.

OBJECTIVES: To determine if children with cystic fibrosis (CF) who are otitis media prone and treated with tympanostomy tube placement (TTP) follow the natural course of non-CF children regarding the incidence of tympanostomy tube otorrhea (TTO) (21-34%). METHODS: All CF patients seen at a large tertiary pediatric hospital were retrospectively reviewed from 2010 to 2019. A total of 483 patients were identified and seventeen met the inclusion criteria and were included in the analysis. Data collected included demographics, CF diagnosis history including date of diagnosis and genotype, TTP notes, and otorrhea found in otolaryngology clinic and pediatrician clinic notes for up to 18 months post-TTP. RESULTS: CF was diagnosed at a median age of 13 days (0 days to 6 years). In terms of surgical frequency, 14/17 (82.4%) patients had one TTP, 2/17 (11.8%) had two TTPs, and 1/17 (5.9%) had five TTPs. The median (range) age at first TTP was 2 years (3 months to 13 years). After the first TTP, TTO occurred in 5 (29.4%) patients at 3 months, 6 (35.3%) at 6 and 9 months, and 7 (41.2%) at 12 and 18 months at median (range) = 1 (0-5) otolaryngology appointments and median (range) = 0 (0-8) pediatrician appointments. CONCLUSION: To our knowledge this is the first study to report that CF children are more likely to be severely affected with recurrent acute otitis media (RAOM), to require TTP, and to exhibit a natural history of TTO commensurate with the non-CF population.

Cystic fibrosis mutation classes in pediatric otitis media - Fickle or faulty?

PURPOSE: Recent data have challenged the historical paradigm that cystic fibrosis (CF) protects against otitis media (OM). These findings raised questions about the pathogenesis of this ostensible change. In this study our aim is to characterize acute OM (AOM) risk based on CF genotype. METHODS: A retrospective chart review was completed at a tertiary care pediatric hospital. Charts of 159 CF patients seen at our facility from 2010 to 2019 were reviewed. Data collected included demographics, AOM infections, cystic fibrosis transmembrane conductance regulator (CFTR) allele mutations, pulmonary exacerbations (PE), and pancreatic insufficiency (PI) status. Mutation alleles were divided into five classes based on CF guidelines, which were further classified as severe (classes I-III) or mild (classes IV-V). RESULTS: 54% of patients had at least one episode of AOM with a mean of 1.5 episodes of AOM (standard deviation = 2.3). 86% of patients had severe/severe (S/S) alleles and 14% had severe/mild (S/M). S/S patients had significantly more PE (p = .004) and increased rates of PI (p < .001). Of the 131 patients with S/S mutations, 57% had an episode of AOM while only 46% the 22 S/M patients had an AOM episode (p = .357). CONCLUSIONS: To our knowledge this is the first report showing a clinical trend towards increased middle ear disease in patients with severe CFTR mutations. Future prospective studies will be powered to demonstrate whether this trend is statistically significant. Patients with S/S mutations not only have more severe clinical phenotypes but may have additional unexpected complications such as middle ear disease.

Consideration of Cough Reflex Development When Ordering Modified Barium Swallow Studies in Infants.

Infants < 51 weeks post-menstrual age (< 51 PMA) are often referred for modified barium swallow (MBS) studies for suspected silent aspiration (SA) given a possible association between SA and aspiration pneumonia. Infants this young are unlikely to have developed a mature laryngeal cough reflex, most likely rendering SA an expected finding in those who aspirate. The aims of this retrospective review were to (1) determine if SA resolves in a significant proportion of infants around the expected emergence of the laryngeal cough reflex, (2) determine which factors or characteristics are associated with and without SA resolution in these infants, and (3) determine if SA, or any aspiration, is associated with increased rates of lower respiratory infection (including aspiration pneumonia) in these infants. Results from the chart review revealed that 79/148 (53.4%) infants had SA on MBS < 51 PMA. 16/48 (33.3%) infants assessed for SA by the time of the expected emergence of the cough reflex had resolution. SA resolution was less common in infants with obstructive sleep apnea (p = 0.037). A total of 50/70 (71.4%) infants with a follow-up MBS had eventual SA resolution. Aspiration was not significantly associated with LRI, including aspiration pneumonia. The results suggested that the laryngeal cough reflex might develop later than reported in the literature and there is no association between aspiration and LRI. These findings may indicate that age should be considered before ordering an MBS solely to assess for SA in this population. The study provides preliminary evidence for future prospective research regarding SA resolution.

Tube patency: Is there a difference following otic drop administration?

PURPOSE: Many surgeons instill peri-operative otic drops to maintain tube patency. A post-hoc analysis of three randomized, controlled studies involving a one-time administration of ciprofloxacin (OTO-201) given instead of otic drops perioperatively was conducted to evaluate tube patency in patients who did and did not receive otic drops as defined within the study protocol. MATERIALS AND METHODS: Post-hoc, retrospective analysis from three prospective, randomized, double-blind trials, (Phase 1b study [n = 83] and two Phase 3 studies [n = 532]) which enrolled children with confirmed middle ear effusion on the day of tympanostomy tube surgery and then randomized to placebo/sham (tubes alone) or OTO-201 and studied over a 28-day observation period. Patients with observed otorrhea post-tube were provided otic drops in the studies. An analysis was performed on the combined studies to evaluate tube patency, determined by pneumatic otoscopy and tympanometry, at four defined study visits over 28 days after the initial tube placement. RESULTS: The analysis included 591 total patients with similar baseline demographics across groups. Tube patency ranged from 87 to 95% for patients who received otic drops, and from 96 to 99% for patients who did not receive otic drops. CONCLUSION: Based on a retrospective post-hoc analysis from three randomized controlled trials in nearly 600 patients, tympanostomy tube occlusion rates was not increased in patients who did not receive otic drops. From this analysis, occlusion is likely caused primarily by peri-operative otorrhea since patency rates approached 99% in the absence of this complication.

Safety and efficacy of intratympanic ciprofloxacin otic suspension post-tubes in a real-world pediatric population.

PURPOSE: Otorrhea frequently follows tympanostomy tube (TT) placement. We evaluated otorrhea following single 6mg OTO-201 (OTIPRIO®, ciprofloxacin otic suspension 6%) intraoperative injection into each middle ear in a variety of effusion types and concurrent procedures in children undergoing TT placement. SECONDARY OBJECTIVE: Efficacy based on Medicaid status and safety. BASIC PROCEDURES: In this prospective, 8-week, multicenter, open-label study, 501 patients were enrolled: mean age 2.9years, male (56.9%), wet/wet ears (66.9%), wet/dry (16.8%), dry/dry (16.3%), and Medicaid-insured (32.9%). MAIN FINDINGS: In per-protocol population (n=410), otorrhea rate through Day 15 were 8.8% (CI:5.7%-12.8%), 6.6% (CI:2.2%-14.7%), 3.3% (CI:0.4%-11.3%) in wet/wet, wet/dry, and dry/dry ears, respectively. For Medicaid patients through Day 15, Week 4 and Week 8, otorrhea rates were 8.1% (CI:4.1%-14.1%), 17.0% (CI:11.1%-24.5%), and 17.8% (CI:11.7%-25.3%) compared with those non-Medicaid insured: 7.3% (CI:4.5%-11.0%), 14.5% (CI:10.6%-19.3%), and 21.8% (CI:17.1%-27.2%), respectively. Safety was similar to previous Phase 3 trials. PRINCIPAL CONCLUSIONS: OTO-201 demonstrated otorrhea rates consistent with Phase 3 trials in a broader, real-world, ENT practice-based pediatric population. Outcomes were similar in Medicaid- and non-Medicaid insured patients. OTO-201 was well-tolerated.

Randomized Clinical Trial of a Sustained-Exposure Ciprofloxacin for Intratympanic Injection During Tympanostomy Tube Surgery.

OBJECTIVE: This exploratory clinical trial evaluated the safety and clinical activity of a novel, sustained-exposure formulation of ciprofloxacin microparticulates in poloxamer (OTO-201) administered during tympanostomy tube placement in children. METHODS: Double-blind, randomized, prospective, placebo- and sham-controlled, multicenter Phase 1b trial in children (6 months to 12 years) with bilateral middle ear effusion requiring tympanostomy tube placement. Patients were randomized to intraoperative OTO-201 (4 mg or 12 mg), placebo, or sham (2:1:1 ratio). RESULTS: Eighty-three patients (52 male/31 female; mean age, 2.80 years) were followed for safety (otoscopic exams, cultures, audiometry, and tympanometry) and clinical activity, defined as treatment failure (physician-documented otorrhea and/or otic or systemic antibiotic use ≥3 days post surgery). At baseline, 14.3% to 36.8% of children showed positive cultures of middle ear effusion samples in at least 1 ear. Through day 15, treatment failures accounted for 14.3%, 15.8%, 45.5%, and 42.9% of patients (OTO-201 4 mg, OTO-201 12 mg, placebo, and sham, respectively); treatment failure reductions for OTO-201 doses were significant compared to pooled control (P values = .023 and .043, respectively). Observed OTO-201 safety profile was indistinguishable from placebo or sham. CONCLUSIONS: Results of this first clinical trial suggest that OTO-201 was well tolerated and shows preliminary clinical activity in treating tympanostomy tube otorrhea.

Characteristics and management of pediatric medial subperiosteal orbital abscesses.

INTRODUCTION: Subperiosteal orbital abscesses (SPOA) are the most common suppurative complications of acute bacterial sinusitis. Medial SPOAs arise from infection of the ipsilateral ethmoid sinus and favor initial conservative management reserving surgical drainage for patients who do not demonstrate clinical improvement. No standard algorithm defining medical versus surgical treatment of medial SPOAs exist in the pediatric population. OBJECTIVES: To identify a size cutoff for medial SPOAs to predict the likelihood for surgical drainage. METHODS: This is a retrospective review of patients with medial SPOAs at a tertiary care center from 2003 to 2017. Diagnosis of SPOA was based on radiographic findings. Variables included are patient demographics, antibiotic therapy, surgical intervention, and length of stay. RESULTS: 82 patients with a medial SPOA were included with an average age at presentation of 6.27 (range 0-15) years were included in this study. 62 patients were male (75.6 %), and 20 were female (24.4 %). The average abscess length was 16.1 mm, range 4.5-30.7 mm. The average abscess width was 4.17 mm, range 1.5-14.6 mm. The odds ratio for surgical treatment with every 1 mm increase in abscess width was 1.89 (95CI:1.33-2.69, p < 0.001). Abscesses over 3.6 mm width were 6.65 times more likely to undergo surgical drainage than those less than 3.6 mm (OR:6.65, 95CI:2.52-17.54, p < 0.001). The average(SD) length of stay was 5.4(3.0) days for patients who underwent surgery and 4.0(0.9) days for patients treated with conservative measures, p < 0.001. CONCLUSION: Medial SPOAs greater than 3.6 mm were more likely to undergo surgical drainage; however there was no difference in the likelihood of drainage between anteriorly and posteriorly based medial abscesses. These findings help further characterize the landscape of pediatric subperiosteal abscesses that are managed with surgical drainage.

Pediatric otolaryngology telemedicine amid a pandemic - And beyond.

INTRODUCTION: The coronavirus disease of 2019 (COVID-19) pandemic catalyzed an unprecedented redesign and innovative overhaul of health care delivery thrusting from fringe to mainstream virtual care. With a return to conventional practice, we now must create a research and policy agenda using the changes wrought by COVID-19 to help create a better health care system in its aftermath. The purpose of this study was to assess satisfaction of otolaryngology outpatient visits during the pandemic. METHODS: A prospective survey study was performed on caregivers of all patients ages 0-26 years old seen in the Division of Pediatric Otolaryngology at our large tertiary care children's hospital from February-April 2020. The three study groups were those seen in-person 6 weeks before telemedicine was implemented (IBTM), those seen in telemedicine during the first 6 weeks (TM) it was implemented at our hospital, and those seen in-person during the telemedicine period (IDTM) in the same timeframe. The survey consisted of satisfaction questions related to their visit, if their child was recommended surgery at the time of the visit, and if the caregiver agreed with the recommendation. A medical record review was also performed. RESULTS: A total of 176 caregivers completed the survey with 113(64.2%) completing the survey for an IBTM appointment, 59(33.5%) for a TM appointment, and 4(2.3%) for an IDTM appointment. There were 100(56.8%) male patients and 167(94.9%) were white. Families gave a higher response for the statement "The ability to communicate with the physician" (p = .012) and "The overall outpatient experience" (p = .004) in the IBTM cohort compared to the TM group. There were no significant differences for the other statements regarding the ability to understand recommendations, courtesy, and knowledge of the physician. Regardless of group, 98.6% of caregivers agreed with surgical recommendation when surgery was recommended. However, when surgery was not recommended at the appointment, caregivers were 11x more likely to disagree with the surgical recommendations, OR:11.49,95%CI:1.44-91.38,p = .005. CONCLUSION: We conclude that telemedicine was equally well received by patients as compared to traditional live assessments suggesting that virtual care is a viable post-pandemic paradigm change. Satisfaction was rated as "Good" or "Excellent", however, messaging when surgery is not recommended was less acceptable and must be improved to obtain increased caregivers' agreement in an era of shared decision making.

It's a rash: Antibiotic allergies in the modern era of antibiotic stewardship.

OBJECTIVES: To determine whether current guidelines emphasizing antibiotic stewardship in pediatrics have been associated with reduced prevalence of antibiotic allergies in children severely affected by otitis media undergoing bilateral myringotomy with tympanostomy tube insertion (BMT) or by recurrent sinusitis or adenotonsillitis undergoing adenoidectomy with or without tonsillectomy. METHODS: Case series of consecutive patients undergoing BMT or adenoidectomy with/without tonsillectomy for recurrent acute otitis media, recurrent sinusitis, or recurrent tonsillitis during November 2008 or November 2017 at a tertiary care children's hospital. Children with primarily obstructive indications for surgery, with prior tube placement or adenoidectomy, or with surgery by an outside provider were excluded. Demographics, type of surgery, and allergies or allergic symptoms were collected from the electronic medical record. Factors associated with antibiotic allergies were compared using logistic regression, Wilcoxon rank-sum, or Chi-squared test. RESULTS: Seventy-five children who underwent surgery during 2008 and 75 children who underwent surgery in 2017 were included. Overall, median age at surgery was 3.24 years (range 0.56-17.49 years). Seventy-nine (52.7%) patients were female and 95 (63.3%) had private insurance. BMT was the most common surgery (82 children, 54.7%) followed by tonsillectomy with adenoidectomy (46 children, 30.7%), and adenoidectomy without tonsillectomy (39 children, 26.0%). Symptoms of allergic rhinitis were reported by 53 (35.3%) patients, and 11 (7.3%) and 5 (3.3%) had positive environmental and food allergy testing, respectively. Surprisingly, there was not a significant difference between the prevalence of antibiotic allergies in patients undergoing surgery during 2017 (17 patients, 22.7%) compared with 2008 (14 patients, 18.7%) (OR: 1.28, 95% CI: 0.578-2.82, p = 0.546). However, antibiotic allergies were less common in females (OR: 0.413, 95% CI: 0.182-0.937, p = 0.034) and more common in patients with a family history of antibiotic allergies (OR: 36.9, 95% CI: 5.12-∞, p < 0.001). CONCLUSION: Pediatric otolaryngology surgical patients continue to exhibit a similar and high prevalence of antibiotic allergies in 2017 compared with 2008. Future studies are needed to determine whether this is because of overdiagnosis of antibiotic allergies or a failure of antibiotic guideline adherence to reduce antibiotic allergy prevalence.

Pediatric subperiosteal orbital abscess characterization and prediction of size, location, and management.

INTRODUCTION: Subperiosteal orbital abscess (SPOA) is a serious suppurative complication of pediatric sinusitis. The objective of this study is to stratify patient selection into those best treated medically versus surgically based on clinical outcomes. METHODS: This is a retrospective review of patients diagnosed with SPOA complicating sinusitis treated at a tertiary care pediatric hospital from 2002 through 2016. SPOA was diagnosed by CT scan. Characteristics evaluated include demographics, abscess size, location, and measurements, length of hospital stay, medical and surgical interventions, presenting symptoms, and complications. RESULTS: A total of 108 total SPOA secondary to sinusitis patients were included. A majority, 72.2%, were male with an average age at presentation of 6.8 years. The mean ± standard deviation abscess cubic volume was 0.98 ± 1.27 cm3 (median(range) = 0.44(0.01-7.34 cmcm3)). With an abscess volume of 0.510 cm3, there was a sensitivity of 71.2% and a specificity of 84.4% for needing surgical drainage. Those with large abscesses at our volume threshold were 13 times more likely to require surgery than those with small abscesses, OR: 13.41, 95%CI: 5.02-35.86, p < .001. Patients that required surgery had an abscess closer to the orbital apex with the majority, 25 (61.0%), being the most proximal to the apex, p = .004. The likelihood of surgery decreased with increased distance from the orbital apex in medial abscesses (OR:.92, 95%CI: 0.86-0.98, p = .009). CONCLUSION: In the pediatric population, SPOA is a serious consequence of sinusitis. This study provides evidence supporting that larger abscess size is a significant risk factor for requiring surgery. The appeal of our study is that it provides evidence and support that employ clinical parameters already assessed as standard practice in evaluating these patients. In summarizing the clinical translational relevance of our study, when determining whether to treat a patient with surgery and antimicrobial/medical therapy vs. non-surgical medical therapy alone, the clinician should focus on size of 0.510 cm3 or larger for abscesses in any location as a relative indication for surgery.

Cognitive Mechanisms in Pediatric Voice Therapy - An Initial Examination.

INTRODUCTION: Voice disorders are a common communication disorder in children. Behavioral voice therapy is recommended by both Otolaryngologists and Speech-Language Pathologists as a first-line approach for treatment of benign vocal fold lesions that affect children in large numbers. However, the role of cognitive mechanisms critical to voice therapy have not yet been explored. OBJECTIVE: This proof-of-concept study aims to provide preliminary data on the potential relation between cognitive abilities and behavioral results of voice therapy for children with benign phonotraumatic vocal fold lesions. METHODS: Six children (4;05 -9;02 years) diagnosed with vocal fold nodules completed a battery of cognitive tests from the NEuroPSYchological (NEPSY-II) Assessment and a standard course of "Adventures in Voice" therapy. Recordings pre and post intervention were analyzed acoustically using the Cepstral Spectral Index of Dysphonia (CSID) and perceptually using visual analog scales (VAS) for severity and resonance separately. Raw and age-corrected scaled scores from the NEPSY-II were then examined for their possible relation to voice outcomes. RESULTS: Multiple cognitive functions correlated with voice outcomes. Raw score measures for Design Fluency, Inhibition, Fingertip Tapping, and Narrative Memory correlated favorably with all voice outcome measures. Age correlated with all NEPSY-II raw scores and perceptual voice outcome measures. Scaled scores for Auditory Attention, Design Fluency, Fingertip Tapping (Dominant hand), and Narrative Memory correlated with all voice outcome measures. CONCLUSION: Results suggest that there is merit to further investigation of the relation between cognitive skills and their development and voice treatment outcomes in children with benign phonotraumatic lesions. Future studies with larger samples will build on present findings.

Infant aspiration and associated signs on clinical feeding evaluation.

OBJECTIVES: Few studies have examined clinical signs of aspiration in infants <51 weeks post-menstrual age (PMA) for whom the laryngeal cough reflex is not fully developed. This retrospective study explored 1) the association between signs of aspiration on a clinical feeding evaluation (CFE) and/or comorbid conditions with aspiration (silent or overt) on a modified barium swallow study (MBS) for infants in this age range, 2) the association between lower respiratory infection (LRI) and aspiration on MBS, and 3) the sensitivity and specificity of detecting aspiration according to signs on CFE and the evaluating speech-language pathologist's (SLP) years of experience. METHODS: A retrospective review of charts of patients with MBS completed January 1, 2012-December 31, 2014 was performed. Patients were included if they were <51-weeks PMA at the time of MBS and had a CFE conducted no more than seven days prior to the MBS. Patient age, comorbidities, and MBS and CFE details were collected. The impact of CFE findings, patient age, comorbid syndromes/associations, and aerodigestive diagnoses on the odds of demonstrating silent aspiration (SA) or overt aspiration during MBS with thin liquids was determined using logistic regression, and the sensitivity and specificity of CFE for identifying SA was calculated. RESULTS: Results from 114 patients indicated that 46 (40 %) of the infants had SA and nine (8 %) had overt aspiration on MBS. Notable signs on CFEs were cough (36 %), oxygen desaturations (33 %), and chest congestion (32 %). On multiple regression analysis there was increased odds of SA on MBS with at least one clinical sign on CFE (OR: 24.3, p = 0.02), chronic lung disease, (OR: 18.2, p = 0.01), and airway abnormalities (OR: 2.94, p = 0.01). Cough on CFE was associated with increased odds of overt aspiration on MBS (OR: 5.69, p = 0.04). Neither SA nor overt aspiration were significantly associated with LRI. Sensitivity and specificity of CFE for correctly identifying the presence of SA were 98 % and 15 %, respectively; experience of the SLP was not a contributing factor. CONCLUSION: Further study is required to determine if specific signs on CFE are predictive of aspiration.

Lesion-Mapping Software for the Measurement of Subperiosteal Abscess Volume for Pediatric Orbital Cellulitis: A Retrospective Chart Review.

INTRODUCTION: Our objective was to assess the utility of using lesion-mapping software to calculate precise orbital volumes to predict patients who would benefit from early surgical intervention. METHODS: We retrospectively reviewed patients diagnosed with subperiosteal orbital abscess (SPOA) secondary to sinusitis at a tertiary pediatric hospital from 2005 to 2016. Diagnoses were confirmed by CT scans. Lesion-mapping software was used to measure SPOA volume using initial CT images. Data collected included patient demographics, length of hospital stay, and subsequent medical or surgical treatment. RESULTS: Thirty-three (52%) patients ultimately underwent surgical intervention, while 30 (48%) were managed medically. Between the surgical and medical groups, there were no differences in gender, age, or comorbidities. The surgical group had larger abscess volumes than the medically managed group (0.94 mL vs. 0.31 mL, p < 0.01). Overall, increased SPOA volume was associated with increased age (Pearson's coefficient = 0.374, p ≤ 0.01) and increased total days of intravenous (IV) antibiotic administration (Pearson's coefficient = 0.260, p = 0.039). Patients who underwent surgery on the day of admission had 25% shorter hospital stay than patients who had delayed surgery (p < 0.01). Our calculated sensitivity-optimized SPOA volume cutoff of 0.231 mL yielded sensitivity of 90.9% and specificity of 70.0%. CONCLUSIONS: This is the first study to use lesion-mapping software for precise calculation of SPOA volumes, which can help refine indications for early surgical intervention and help decrease length of hospital stay.

Evidence-based telehealth clinical pathway for pediatric tympanostomy tube otorrhea.

INTRODUCTION: As healthcare moves away from volume-based to value-based delivery models, evidence based clinical pathways detail essential steps in patient care to reduce the costs and utilization of health care resources. Ideal pathways lead towards standardized, patient-centered care through an algorithm that is evidence-based, interventions with criteria-based progression, and measurable endpoints or quality indicators. Using these standards, a clinical pathway for managing tympanostomy tube otorrhea beginning with phone triage was developed in accordance with AAO-HNSF Guidelines. METHODS: A retrospective case series of all consecutive patients calling the otolaryngology nurse's line at a tertiary pediatric hospital 3/2018-11/2018 regarding otorrhea was performed. Nurses completed a standardized and evidence-based form based on parent responses regarding purulence, tympanostomy tubes/perforation, fever>102°, ear redness, bacterial rhinosinusitis, sore throat, and immunodeficiency, which was sent to the advanced practice providers (APPs) to assess for antibiotic drops. Otorrhea form information and tympanostomy tube history, subsequent phone calls, clinic visits, and antibiotic prescriptions for otorrhea were extracted. RESULTS: Eighty-two patients were included. Median child age at phone call was 2.5 years (range 0.3-20.2 years), and 45.1% were female. All patients had prior tubes and active purulent otorrhea. No parents reported cellulitis or immunodeficiency. One patient had symptoms of bacterial rhinosinusitis and a sore throat but had already been seen by their primary care provider (PCP) for systemic antibiotics. Antibiotic drops were prescribed by an APP in 96.3% of cases [ofloxacin (n = 57), ciprofloxacin (n = 17), or ciprofloxacin with dexamethasone (n = 5)]. The remaining patients already had drops (2.5%) or were referred to their PCP (1.2%). Twenty (24.4%) received another antibiotic prescription and 17.1% had a subsequent clinic or urgent care visit for otorrhea. CONCLUSIONS: This pathway obviated clinic visits in 82.9% of patients with a 75.6% treatment cure.

Heterotopic gastric mucosa of the proximal esophageal (HGMPE) and its potential role in pediatric dysphonia and dysphagia.

OBJECTIVE: Despite a reported incidence of HGMPE of 10%, proof of acid production, and an increased incidence of respiratory symptoms, the pediatric otolaryngology, swallowing and voice care literature is silent on this entity. This case series describes pediatric patients confirmed to have HGMPE with dysphonia and/or dysphagia. METHODS: Retrospective case series of Pediatric Voice, Resonance, and Swallowing Center patients at a tertiary Children's Hospital in 2019. SETTING: Tertiary academic medical center. SUMMARY OF RESULTS: Three patients who underwent triple endoscopy for dysphonia or dysphagia were histologically diagnosed with HGMPE. Esophageal biopsies were otherwise normal. Two of the three patients resolved their primary aerodigestive symptoms following treatment with acid suppression and a protectant (sucralfate). The third patient reported significant improvement in symptoms by phone. The significance of this case series cannot be understated: 1) A need for increased awareness among pediatric otolaryngologists, voice care and swallowing professionals of this entity given its relatively common incidence of 10% offset by a dearth of presentations & scientific publications in our literature clearly exists. 2) Otolaryngologists have abandoned operative upper aerodigestive tract endoscopy in lieu of office-based less comprehensive videolaryngostroboscopy and fiberoptic endoscopic evaluation of swallowing. HGMPE & other esophageal disorders (i.e. eosinophilic esophagitis) support revisiting triple endoscopy in select patients where office endoscopy has failed to diagnose and successfully treat such patients. 3) Both acid suppression therapy and a protectant (sucralfate) may be useful in these patients. 4) Modification of rigid esophagoscopy technique to carefully assess the introitus and superior esophageal segment is paramount 5) Otolaryngologists over-diagnose & over-treat laryngopharyngeal reflux. The pediatric & adult literature is replete with significant safety warnings associated with acid suppression therapy and guidelines admonish their indiscriminate use, raising the liability bar of empiric treatment. Large scale prospective, randomized and controlled studies are needed to confirm the pathophysiologic role of this entity in pediatric aerodigestive disorders. CONCLUSION: HGMPE is a clinical entity that can be easily missed upon swift entry into the esophagus with rigid endoscopy. Careful scrutiny and visualization of the proximal esophagus is critical in order to identify HGMPE, as there is a higher rate of laryngospasm, stricture, and potentially neoplasm in this population.

Middle ear disease in CF? It's not just about the sinuses anymore!

INTRODUCTION: Historically cystic fibrosis (CF), in contrast to primary ciliary dyskinesia (PCD), has been considered protective of the middle ear from otitis media and rarely were such patients "severely affected" to require tympanostomy tube placement (BMT). Previously the Pittsburgh Otitis Media Research group reported a 10% prevalence of otitis media in the pediatric CF population which is significantly lower than age matched non-CF children. We studied the prevalence of OM in pediatric CF patients to assess if the otologic phenotype has changed in parallel with changes in the diagnosis itself. METHODS: The medical records of 133 CF patients seen either inpatient or outpatient from one of the largest tertiary pediatric CF centers in the world from 2010 to 2019 were reviewed for demographics, acute otitis media (AOM) episodes, risk factors for AOM, placement of myringotomy tubes, genotype, BMI, pancreatic status, respiratory culture results, and pulmonary exacerbations. RESULTS: Just over half (52.6%) the patients were male. A median age for CF diagnosis was 11 days old (range 0 days-16 years). The most common genotype (49.6%) was homozygous for ΔF508 mutation. Fifty-five (41.4%) patients had 1-2 episodes of AOM, and 15 (11.3%) were severely affected (i.e. ≥3 episodes/6 months or ≥4 episodes/year). COME was diagnosed in 4 (3.0%) of the patients. Twelve (9.0%) patients had tympanostomy tubes at least once, including 3 patients with multiple sets of tubes. Having at least one AOM episode was not predicted by genetic mutation groups, BMI, age at diagnosis, or comorbidities, p > .05. CONCLUSIONS: The time-honored adage of CF protecting against otitis media is no longer true and pediatric otolaryngologists must now prioritize the management of middle ear disease as highly as sino-nasal and pulmonary disease. Future study into mechanisms explaining the change is needed.

Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension for the topical treatment of ear infections: a review of the literature.

The objective of this article is to review the literature related to ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension. A systematic literature search utilizing Medline was conducted to identify peer-reviewed articles related to safety and efficacy. A total of 47 publications were identified and reviewed herein. The literature supports the use of antibiotic/antiiflammatory combination ear drops in the treatment of both acute otitis externa and acute otitis media in pediatric patients with tympanostomy tubes. Ciprofloxacin/dexamethasone has been demonstrated as safe and effective with regard to clinical cures and microbiological eradication of pathogens in either disease with low treatment failure rates. Additionally, the literature also provides clear evidence for the contribution of dexamethasone when added to ciprofloxacin for the topical treatment of ear infections.