Paediatric sleep apnea event prediction using nasal air pressure and machine learning.

Sleep-disordered breathing is an important health issue for children. The objective of this study was to develop a machine learning classifier model for the identification of sleep apnea events taken exclusively from nasal air pressure measurements acquired during overnight polysomnography for paediatric patients. A secondary objective of this study was to differentiate site of obstruction exclusively from hypopnea event data using the model. Computer vision classifiers were developed via transfer learning to either normal breathing while asleep, obstructive hypopnea, obstructive apnea or central apnea. A separate model was trained to identify site of obstruction as either adeno-tonsillar or tongue base. In addition, a survey of board-certified and board-eligible sleep physicians was completed to compare clinician versus model classification performance of sleep events, and indicated very good performance of our model relative to human raters. The nasal air pressure sample database available for modelling comprised 417 normal, 266 obstructive hypopnea, 122 obstructive apnea and 131 central apnea events derived from 28 paediatric patients. The four-way classifier achieved a mean prediction accuracy of 70.0% (95% confidence interval [67.1-72.9]). Clinician raters correctly identified sleep events from nasal air pressure tracings 53.8% of the time, whereas the local model was 77.5% accurate. The site of obstruction classifier achieved a mean prediction accuracy of 75.0% (95% confidence interval [68.7-81.3]). Machine learning applied to nasal air pressure tracings is feasible and may exceed the diagnostic performance of expert clinicians. Nasal air pressure tracings of obstructive hypopneas may "encode" information regarding the site of obstruction, which may only be discernable by machine learning.

Opioid prescribing practices in academic otolaryngology: A single institutional survey.

OBJECTIVES: Opioids are highly addictive medications and otolaryngologists have a responsibility to practice opioid stewardship. We investigated postoperative opioid prescribing patterns among resident and attending physicians as an educational platform to underscore the importance of conscientious opioid prescribing. METHODS: This quality improvement study was designed as a cross-sectional electronic survey. Residents and attending clinical faculty members at a single academic institution were queried from February through April 2020. An electronic survey was distributed to capture postoperative opioid prescribing patterns after common procedures. At the conclusion of the study, results were sent to all faculty and residents. RESULTS: A total of 29 attending otolaryngologists and 22 residents completed the survey. Resident physicians prescribed on average fewer postoperative opioid pills than attendings. Among attendings, the largest number of opioids were prescribed following tonsillectomy (dose varied by patient age), neck dissection (12.6 pills), brow lift (13.3 pills), facelift (13.3 pills), and open reduction of facial trauma (10.7 pills). For residents, surgeries with the most postoperatively prescribed opioids were for tonsillectomy (varied by patient age), neck dissection (13.4 pills), open reduction of facial trauma (10.5 pills), parotidectomy (10.0 pills), and thyroid/parathyroidectomy (9.0 pills). The largest volume of postoperative opioids for both groups was prescribed following tonsillectomy. Attendings prescribed significantly more opioids after facelift and brow lift than did residents (p = 0.01 and p = 0.003, respectively). CONCLUSION: There was good concordance between resident and attending prescribers. Improvement in opioid prescribing and pain management should be an essential component of otolaryngology residency education and attending continuing medical education. LEVEL OF EVIDENCE: 4.

Use of imaging to evaluate course of the carotid artery in surgery for velopharyngeal insufficiency.

OBJECTIVE: This study aimed to describe syndromes where preoperative imaging may be essential in determining the course of the carotid arteries before velopharyngeal insufficiency (VPI) surgery and therefore affect surgical planning. METHODS: Records of children who underwent surgery for VPI between May 1, 2012, and October 30, 2013, at a tertiary care pediatric otolaryngology center were reviewed. Data collected included age at operation, preoperative and postoperative nasometry values, presence of underlying genetic disorders, and imaging findings. RESULTS: Twenty-five patients underwent 33 surgeries for VPI, with 1 posterior pharyngeal wall augmentation, 6 Furlow palatoplasties, 11 sphincter pharyngoplasties, and 15 pharyngeal flaps. Medialized carotid vasculature was identified in 5 of 25 patients (20%). Seven syndromic patients were identified, with 3 patients having 22q11.2 deletion syndrome. All patients (100%) with 22q11.2 deletion syndrome had medialized carotid arteries. Of the 4 additional syndromic children, 2 (50%) had medial internal carotid arteries, with 1 patient diagnosed with neurofibromatosis 1 and another with Prader-Willi syndrome. Both patients underwent Furlow palatoplasty. CONCLUSION: Whereas 22q11.2 deletion syndrome is recognized as an entity where a medial carotid is often present, other syndromic children may also demonstrate vascular variability. Although a larger study is needed to confirm an increased prevalence in these patients, clinicians may need a higher degree of suspicion while performing the physical examination. If examination findings are suggestive or the disease process may lend itself to this abnormality, vascular imaging can be considered as part of presurgical planning to help guide surgical technique and prevent complications.

Operation airway: the first sustainable, multidisciplinary, pediatric airway surgical mission.

OBJECTIVE: This study aimed to describe the development and implementation of the first sustainable, multidisciplinary, pediatric airway surgical mission in an underserved country. METHODS: This prospective, qualitative study was conducted for the first 4 Operation Airway missions in Quito, Ecuador. The major goals of the missions were to assist children with aerodigestive abnormalities, create a sustainable program where the local team could independently provide for their own patient population, develop an educational curriculum and training program for the local team, and cultivate a collaborative approach to provide successful multidisciplinary care. RESULTS: Twenty patients ages 4 months to 21 years were included. Twenty-three bronchoscopies, 5 salivary procedures, 2 tracheostomies, 1 T-tube placement, 1 tracheocutaneous fistula closure, 2 open granuloma excisions, and 6 laryngotracheal reconstructions (LTRs) were performed. All LTR patients were decannulated. A new type of LTR (1.5 stage) was developed to meet special mission circumstances. Two videofluoroscopic swallow studies and 40 bedside swallow evaluations were performed. One local pediatric otolaryngologist, 1 pediatric surgeon, 3 anesthesiologists, 7 intensivists, 16 nurses, and 2 speech-language pathologists have received training. More than 25 hours of lectures were given, and a website was created collaboratively for educational and informational dissemination (http://www.masseyeandear.org/specialties/pediatrics/pediatric-ent/airway/OperationAirway/). CONCLUSION: We demonstrated the successful creation of the first mission stemming from a teaching institution with the goal of developing a sustainable, autonomous surgical airway program.

Optimizing Inspire Hypoglossal Nerve Stimulator Settings in Pediatric Obstructive Sleep Apnea.

INTRODUCTION: Hypoglossal nerve stimulation (HGNS) is an effective therapy for carefully selected pediatric patients with Down syndrome (DS) and obstructive sleep apnea (OSA), but optimization of device settings has been focused on stimulation settings. The potential benefits of sensing lead setting optimization have not been investigated. We describe a series of three cases of HGNS in children with DS where optimization of both the stimulation lead and sensing lead settings, as well as utilization of drug-induced sleep endoscopy (DISE), when indicated, was more effective than stimulation lead optimization alone. METHODS: Using our novel titration algorithm, among the three identified pediatric patients with DS in whom HGNS initially failed to reduce the apnea-hypopnea index (AHI), two patients in whom sleep studies were characterized as hypopnea-dominant were assigned to advanced titration (optimization of stimulation settings and sensing lead settings). The third patient, with an obstructive apnea-dominant sleep study, was referred for interrogated DISE. Advanced titration included adjustment of both stimulation settings and sensing lead settings. RESULTS: Application of the advanced titration algorithm, tailored to obstructive apnea- versus hypopnea-dominant sleep patterns, resulted in approximately 50% or greater reduction in AHI in all three patients. "Normal to mild OSA" AHI (AHI <5) was achieved in two patients. CONCLUSIONS: A novel diagnostic and therapeutic titration algorithm for the Inspire HGNS system significantly reduced AHI in three pediatric patients with DS and OSA who had failed to respond to the standard device titration that focused solely on stimulation settings. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in a Young Child With Down Syndrome.

Obstructive sleep apnea (OSA) is common in children with Down syndrome (DS). Adenoidectomy and/or tonsillectomy are the usual first interventions employed to treat OSA in children with DS but sometimes do not achieve adequate resolution of clinical signs. Positive airway pressure treatment is often used next, but this treatment is poorly tolerated by this population. Persistent OSA can adversely affect a child's health and cognitive development. Hypoglossal nerve stimulation (HGNS), previously shown to be safe and effective in adults with OSA, has been used in children as young as 10 years old with DS and has achieved measurable neurocognitive benefits. The US Food and Drug Administration recently lowered the age for HGNS implantation to 13 years for children with DS. However, questions remain regarding treatment of refractory OSA in younger children. Here, we report the case of a 4-year-old boy with DS and treatment-refractory OSA who underwent successful HGNS implantation. The decision to proceed with HGNS implantation in such a young child involved discussions about anatomic feasibility and potential neurocognitive benefits. The device was implanted without complication and with minimal postoperative bulk. This case suggests a possible treatment option that can be discussed in the course of shared decision-making between clinicians and families of young children with DS and treatment-refractory OSA.

Sustainable improvement in upstream and downstream outcomes for intubated patients three years after an airway-based educational intervention in a low-resource pediatric intensive care unit.

OBJECTIVE: To determine whether implementation of an education-based intervention can sustainably improve upstream and downstream outcomes in intubated patients in a pediatric intensive care unit (PICU) in a low-resource country. DESIGN: Quality improvement study comparing airway-related morbidity in two previously studied patient cohorts pre-intervention (Epoch 1) and immediately post-intervention (Epoch 2) with a third cohort thirty-six months post-intervention (Epoch 3). SETTING: PICU of the largest public children's hospital in El Salvador. PATIENTS: 147 patients under 18 years requiring intubation and mechanical ventilation (MV) met inclusion criteria in the long-term follow-up period and were consecutively sampled without exclusion (Epoch 3) (compared to 98 previously studied patients in the short-term follow-up period (Epoch 2)). INTERVENTION: A low-cost, education-based intervention to close knowledge gaps, improve communication among PICU doctors, nurses, and respiratory therapists, and optimize patient outcomes. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was change in unplanned extubation (UE) between Epochs 2 and 3. Other outcomes included use of cuffed endotracheal tubes (ETT), rate of elective ETT change and days of MV. The 17 % decrease in UE previously reported for Epoch 2 was sustained in Epoch 3. There was a statistically significant increase in use of cuffed ETT from 35.7 % in Epoch 2-55.1 % in Epoch 3 (p = 0.003, z-score -2.99). There was also a statistically significant mean difference in rate of elective ETT change per 100 MV days from Epoch 2 to Epoch 3 of 1.7 (p = 0.007; 95 % CI 0.15-0.84). There was no change in MV days from Epoch 2 to Epoch 3 (p-value 0.764; 95 % CI -1.48-2.02). Beyond these quantifiable results, many unanticipated practice changes were observed three years after the initial intervention. CONCLUSIONS: Sustained improvement in upstream and downstream outcomes (UE, cuffed ETT use, elective ETT change) for intubated patients in a low-resource PICU were observed three years after a low-cost, low-touch, education-based intervention.

Practical quality improvement changes for a low-resourced pediatric unit.

Background: This work describes a sustainable and replicable initiative to optimize multi-disciplinary care and uptake of clinical best practices for patients in a pediatric intensive care unit in Low/Middle Income Countries and to understand the various factors that may play a role in the reduction in child mortality seen after implementation of the Quality Improvement Initiative. Methods: This was a longitudinal assessment of a quality improvement program with the primary outcome of intubated pediatric patient mortality. The program was assessed 36 months following implementation of the quality improvement intervention using a t-test with linear regression to control for co-variates. An Impact Pathway model was developed to describe potential pathways for improvement, and context was added with an exploratory analysis of adoption of the intervention and locally initiated interventions. Results: 147 patients were included in the sustainability cohort. Comparing the initial post-implementation cohort to the sustainability cohort, the overall PICU unexpected extubations per 100 days mechanical ventilation decreased significantly from baseline (6.98) to the first year post intervention (3.52; p < 0.008) but plateaued without further significant decrease in the final cohort (3.0; p = 0.73), whereas the mortality decreased from 22.4 (std 0.42) to 9.5% (std 0.29): p value: 0.002 (confidence intervals: 0.05;0.21). The regression model that examined age, sex, diagnosis and severity of illness (via aggregate Pediatric Risk of Mortality (PRISM) scores between epochs) yielded an adjusted R-squared (adjusting for the number of predictors) value of 0.046, indicating that approximately 4.6% of the variance in mortality was explained by the predictors included in the model. The overall significance of the regression model was supported by an F-statistic of 3.198 (p = 0.00828). age, weight, diagnosis, and severity of illness. 15 new and locally driven quality practices were observed in the PICU compared to the initial post-implementation time period. The Impact Pathway model suggested multiple unique potential pathways connecting the improved patient outcomes with the intervention components. Conclusion: Sustained improvements were seen in the care of intubated pediatric patients. While some of this improvement may be attributable to the intervention, it appears likely that the change is multifactorial, as evidenced by a significant number of new quality improvement projects initiated by the local clinical team. Although currently limited by available data, the use of Driver Diagram and Impact Pathway models demonstrates several proposed causal pathways and holds potential for further elucidating the complex dynamics underlying such improvements.

Novel method for laryngotracheal reconstruction: combining single- and double-stage techniques.

OBJECTIVES: Traditional open techniques for laryngotracheal reconstruction are either single- or double-stage procedures. Some patients may benefit from the presence of a long, single-tube stent, such as an endotracheal tube, but their predicted need for a 2-stage procedure and a persistent tracheostomy is high. We describe a novel technique for airway reconstruction that combines the methods of both single- and double-stage procedures. METHODS: We present a retrospective review of 4 patients. All patients underwent laryngotracheal reconstruction by a single surgeon. After the operation, the airway was stented with nasotracheal intubation. A small stent, fashioned from an endotracheal tube, was placed in the tracheostoma to keep it patent. The patients subsequently underwent extubation and replacement of the tracheostomy tube. RESULTS: The study included 1 patient with grade 4 subglottic stenosis, 2 patients with grade 3 subglottic stenosis, and 1 patient with a posterior glottic scar. All were tracheostomy tube-dependent. Serial bronchoscopy was used to follow the patients for a minimum of 9 months after the operation. All 4 patients have since met the criteria for decannulation. CONCLUSIONS: This hybrid reconstruction merges the advantages of both the single- and double-stage procedures. It adds versatility to the surgical toolbox for airway reconstruction.

Growth factor directed chondrogenic differentiation of porcine bone marrow-derived progenitor cells.

BACKGROUND: Despite advances in surgical technique, reconstruction of a mandibular condyle still causes significant donor-site morbidity. The purpose of this study was to compare the effect of 3 different growth factors and define optimal cell culture conditions for bone marrow-derived progenitor cells to differentiate into chondrocytes for mandibular condyle reconstruction. METHODS: Porcine bone marrow-derived progenitor cells (pBMPCs) were cultured as a pellet for 2, 3, and 4 weeks under the following conditions: group 1, TGF-ß3 + standard medium; group 2, TGF-ß3 + BMP-2 + standard medium; group 3, TGF-ß3 + IGF-1 + standard medium; and group 4, TGF-ß3 + BMP-2 + IGF-1 + standard medium. Chondrogenic differentiation was evaluated using 3 lineage differentiation markers. RESULTS: The mean type II collagen positive area increased over weeks 2, 3, and 4 in group 4 compared to all the other groups (ANOVA; P = 0.005). At week 4, there was significantly greater type II collagen production in group 4 compared to all the other groups (ANOVA; P = 0.003). The medium in group 4 produces the greatest amount of cartilage when compared to groups 1, 2, and 3, and that 4 weeks produces the greatest amount of type II collagen. CONCLUSIONS: The results of this study indicate that the most efficacious medium for chondrogenic differentiation of pBMPCs was group 4 medium and the most type II collagen was produced at 4 weeks.

Harnessing the power of electronic health records and open natural language data mining to capture meaningful patient experience during routine clinical care.

INTRODUCTION: Electronic health records (EHR) are a rich data source for both quality improvement and clinical research. Natural language processing can be harnessed to extract data from these previously difficult to access sources. OBJECTIVE: The objective of this study was to create and apply a natural language search query to extract EHR data to ask and answer quality improvement questions at a pediatric aerodigestive center. METHODS: We developed a combined natural language search query to extract clinically meaningful data along with International Statistical Classification of Diseases (ICD10) and Current Procedural Terminology (CPT) code data. This search query was applied to a single pediatric aerodigestive center to answer key clinical questions asked by families. Data were extracted from EHR data from first clinic visit, operative note, microbiology lab report, and pathology report for all new patients from 2020 to 2021. Included as three queries were: 1) if I bring my child to a pediatric aerodigestive center, how often will my child obtain a medical diagnosis without needing an intervention? 2) if my child has a diagnostic procedure, how often will a diagnosis be made? 3) if a diagnosis is made, can it be addressed during that endoscopic intervention? RESULTS: For the 711 new patients coming to the pediatric aerodigestive center from 2020 to 2021, only 26-32% required an interventional triple endoscopy (rigid/flexible bronchoscopy with esophagoduodenoscopy). Of these triple endoscopies, 75.7% resulted in a positive finding that enabled optimization of that child's care. Of the 221 patients who underwent diagnostic triple endoscopies, 40.7% underwent intervention at the same time for laryngeal cleft (injection or suture, dependent upon age). CONCLUSION: Here we created an effective model of open language search query to extract meaningful metrics of patient experience from EHR data. This model easily allows the EHR to be harnessed to create retrospective and prospective databases that can be readily queried to answer clinical questions important to patients. Such databases are widely applicable not just to pediatric aerodigestive centers but to any clinical care setting using an EHR.

"Human vs Machine" Validation of a Deep Learning Algorithm for Pediatric Middle Ear Infection Diagnosis.

OBJECTIVE: We compared the diagnostic performance of human clinicians with that of a neural network algorithm developed using a library of tympanic membrane images derived from children taken to the operating room with the intent of performing myringotomy and possible tube placement for recurrent acute otitis media (AOM) or otitis media with effusion (OME). STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic medical center from 2018 to 2021. METHODS: A training set of 639 images of tympanic membranes representing normal, OME, and AOM was used to train a neural network as well as a proprietary commercial image classifier from Google. Model diagnostic prediction performance in differentiating normal vs nonpurulent vs purulent effusion was scored based on classification accuracy. A web-based survey was developed to test human clinicians' diagnostic accuracy on a novel image set, and this was compared head to head against our model. RESULTS: Our model achieved a mean prediction accuracy of 80.8% (95% CI, 77.0%-84.6%). The Google model achieved a prediction accuracy of 85.4%. In a validation survey of 39 clinicians analyzing a sample of 22 endoscopic ear images, the average diagnostic accuracy was 65.0%. On the same data set, our model achieved an accuracy of 95.5%. CONCLUSION: Our model outperformed certain groups of human clinicians in assessing images of tympanic membranes for effusions in children. Reduced diagnostic error rates using machine learning models may have implications in reducing rates of misdiagnosis, potentially leading to fewer missed diagnoses, unnecessary antibiotic prescriptions, and surgical procedures.

Hospital Prices for Pediatric Tympanostomy Tube Placement and Adenotonsillectomy in 2021.

OBJECTIVES: Hospital prices vary substantially for myringotomy with tympanostomy tube placement (M&T) and adenotonsillectomy (T&A). The Centers for Medicare and Medicaid Services recently implemented hospital price transparency requirements to help families make financially informed decisions about where to seek care. We sought to determine price availability and the extent of price variation for these procedures. METHODS: We performed a cross-sectional analysis of the Turquoise Health Hospital Rates Data Platform, which extracts prices for facility fees from publicly available hospital chargemasters. We determined the proportion of hospitals serving pediatric patients that published payer-specific prices for M&T and T&A. We additionally characterized the extent of variation in payer-specific prices both across and within hospitals. RESULTS: Approximately 40% (n = 909 of 2,266 hospitals) serving pediatric patients disclosed prices for M&T or T&A. Among disclosing hospitals, across-center ratios (adjusted for Medicare hospital wage indices) ranged from 11.0 (M&T; 10th percentile adjusted median price: $536.80 versus 90th percentile adjusted median price: $5,929.93) to 23.4 (revision adenoidectomy age >12 years; 10th percentile: $393.82 versus 90th percentile: $9,209.88). Median within-center price ratios for procedures ranged from 2.2 to 2.7, indicating that some private payers reimbursed the same hospital more than twice as much as other payers for the same procedure. CONCLUSION: The majority of hospitals serving pediatric patients were non-compliant with federal requirements to disclose prices for M&T and T&A. Among disclosing hospitals, there was wide variation in payer-specific prices between and within institutions. Further research is necessary to understand whether disclosure of prices will enable families to make more financially informed decisions. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:948-955, 2023.

Generation of synthetic tympanic membrane images: Development, human validation, and clinical implications of synthetic data.

Synthetic clinical images could augment real medical image datasets, a novel approach in otolaryngology-head and neck surgery (OHNS). Our objective was to develop a generative adversarial network (GAN) for tympanic membrane images and to validate the quality of synthetic images with human reviewers. Our model was developed using a state-of-the-art GAN architecture, StyleGAN2-ADA. The network was trained on intraoperative high-definition (HD) endoscopic images of tympanic membranes collected from pediatric patients undergoing myringotomy with possible tympanostomy tube placement. A human validation survey was administered to a cohort of OHNS and pediatrics trainees at our institution. The primary measure of model quality was the Frechet Inception Distance (FID), a metric comparing the distribution of generated images with the distribution of real images. The measures used for human reviewer validation were the sensitivity, specificity, and area under the curve (AUC) for humans' ability to discern synthetic from real images. Our dataset comprised 202 images. The best GAN was trained at 512x512 image resolution with a FID of 47.0. The progression of images through training showed stepwise "learning" of the anatomic features of a tympanic membrane. The validation survey was taken by 65 persons who reviewed 925 images. Human reviewers demonstrated a sensitivity of 66%, specificity of 73%, and AUC of 0.69 for the detection of synthetic images. In summary, we successfully developed a GAN to produce synthetic tympanic membrane images and validated this with human reviewers. These images could be used to bolster real datasets with various pathologies and develop more robust deep learning models such as those used for diagnostic predictions from otoscopic images. However, caution should be exercised with the use of synthetic data given issues regarding data diversity and performance validation. Any model trained using synthetic data will require robust external validation to ensure validity and generalizability.

AI Model Versus Clinician Otoscopy in the Operative Setting for Otitis Media Diagnosis.

Prior work has demonstrated improved accuracy in otitis media diagnosis based on otoscopy using artificial intelligence (AI)-based approaches compared to clinician evaluation. However, this difference in accuracy has not been shown in a setting resembling the point-of-care. In this study, we compare the diagnostic accuracy of a machine-learning model to that of pediatricians using standard handheld otoscopes. We find that the model is more accurate than clinicians (90.6% vs 59.4%, P = .01). This is a step towards validation of AI-based diagnosis under more real-world conditions. With further validation, for example on different patient populations and in deployment, this technology could be a useful addition to the clinician's toolbox in accurately diagnosing otitis media.

Perioperative dexamethasone administration and risk of bleeding following tonsillectomy in children: a randomized controlled trial.

CONTEXT: Corticosteroids are commonly given to children undergoing tonsillectomy to reduce postoperative nausea and vomiting; however, they might increase the risk of perioperative and postoperative hemorrhage. OBJECTIVE: To determine the effect of dexamethasone on bleeding following tonsillectomy in children. DESIGN, SETTING, AND PATIENTS: A multicenter, prospective, randomized, double-blind, placebo-controlled study at 2 tertiary medical centers of 314 children aged 3 to 18 years undergoing tonsillectomy without a history of bleeding disorder or recent corticosteroid medication use and conducted between July 15, 2010, and December 20, 2011, with 14-day follow-up. We tested the hypothesis that dexamethasone would not result in 5% more bleeding events than placebo using a noninferiority statistical design. INTERVENTION: A single perioperative dose of dexamethasone (0.5 mg/kg; maximum dose, 20 mg), with an equivalent volume of 0.9% saline administered to the placebo group. MAIN OUTCOME MEASURES: Rate and severity of posttonsillectomy hemorrhage in the 14-day postoperative period using a bleeding severity scale (level I, self-reported or parent-reported postoperative bleeding; level II, required inpatient admission for postoperative bleeding; or level III, required reoperation to control postoperative bleeding). RESULTS: One hundred fifty-seven children (median [interquartile range] age, 6 [4-8] years) were randomized into each study group, with 17 patients (10.8%) in the dexamethasone group and 13 patients (8.2%) in the placebo group reporting bleeding events. In an intention-to-treat analysis, the rates of level I bleeding were 7.0% (n = 11) in the dexamethasone group and 4.5% (n = 7) in the placebo group (difference, 2.6%; upper limit 97.5% CI, 7.7%; P for noninferiority = .17); rates of level II bleeding were 1.9% (n = 3) and 3.2% (n = 5), respectively (difference, -1.3%; upper limit 97.5% CI, 2.2%; P for noninferiority < .001); and rates of level III bleeding were 1.9% (n = 3) and 0.6% (n = 1), respectively (difference, 1.3%; upper limit 97.5% CI, 3.8%; P for noninferiority = .002). CONCLUSIONS: Perioperative dexamethasone administered during pediatric tonsillectomy was not associated with excessive, clinically significant level II or III bleeding events based on not having crossed the noninferior threshold of 5%. Increased subjective (level I) bleeding events caused by dexamethasone could not be excluded because the noninferiority threshold was crossed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01415583.

Aspiration does not mean the end of a breast-feeding relationship.

OBJECTIVE: Breastfeeding is widely recommended as optimal nutrition for infants. However, there are no known publications on the impact of prandial aspiration of breast milk fed infants with dysphagia. The goal of this study was to assess pulmonary outcomes in infants with dysphagia who were given medical clearance for intake of breast milk. METHODS: This retrospective cohort study included review of 80 infants examined between August 2016 to March 2021. Patients were evaluated by an interdisciplinary team of providers in a tertiary pediatric aerodigestive center. Patient inclusion criteria included a VFSS with documented aspiration or penetration with thin liquids. Participants met inclusion criteria if given medical clearance for intake of breast milk despite aspiration risk. Pulmonary health was monitored for three months following medical clearance for the consumption of breast milk. Pulmonary illness was defined as development of bronchiolitis, wheezing, unexplained stridor during feeding, croup, pneumonia, or persistent bacterial bronchitis requiring medical intervention. RESULTS: Forty-three males (54%) and 37 females (46%) enrolled in the study with an age range of 1 month-6 months corrected age. Mean age at initial VFSS was 3.6 months. Twenty-six out of 80 (32.5%) had a report of a mild cough but did not require intervention. Eight out of 80 (10%) received a diagnosis of a pulmonary illness. Seventy-two out of 80 (90%) did not report pulmonary illness. CONCLUSION: This pilot study reveals that the majority (90%) of this single institution, small sample size cohort of breast milk fed infants with documented oropharyngeal dysphagia remained healthy despite continued intake of breast milk. Prospective investigation is warranted to follow pulmonary health outcomes longitudinally and a head to head comparative study would be helpful to identify whether there were indeed significant changes to pulmonary health according to differential feeding regimens offered and followed.

Evaluation of Upper Airway Stimulation for Adolescents With Down Syndrome and Obstructive Sleep Apnea.

Importance: Patients with Down syndrome have a high incidence of persistent obstructive sleep apnea (OSA) and limited treatment options. Upper airway hypoglossal stimulation has been shown to be effective for adults with OSA but has not yet been evaluated for pediatric populations. Objective: To evaluate the safety and effectiveness of upper airway stimulation for adolescent patients with Down syndrome and severe OSA. Design, Setting, and Participants: This prospective single-group multicenter cohort study with 1-year follow-up was conducted between April 1, 2015, and July 31, 2021, among a referred sample of 42 consecutive adolescent patients with Down syndrome and persistent severe OSA after adenotonsillectomy. Intervention: Upper airway stimulation. Main Outcomes and Measures: The prespecified primary outcomes were safety and the change in apnea-hypopnea index (AHI) from baseline to 12 months postoperatively. Polysomnographic and quality of life outcomes were assessed at 1, 2, 6, and 12 months postoperatively. Results: Among the 42 patients (28 male patients [66.7%]; mean [SD] age, 15.1 [3.0] years), there was a mean (SD) decrease in AHI of 12.9 (13.2) events/h (95% CI, -17.0 to -8.7 events/h). With the use of a therapy response definition of a 50% decrease in AHI, the 12-month response rate was 65.9% (27 of 41), and 73.2% of patients (30 of 41) had a 12-month AHI of less than 10 events/h. The most common complication was temporary tongue or oral discomfort, which occurred in 5 patients (11.9%). The reoperation rate was 4.8% (n = 2). The mean (SD) improvement in the OSA-18 total score was 34.8 (20.3) (95% CI, -42.1 to -27.5), and the mean (SD) improvement in the Epworth Sleepiness Scale score was 5.1 (6.9) (95% CI, -7.4 to -2.8). The mean (SD) duration of nightly therapy was 9.0 (1.8) hours, with 40 patients (95.2%) using the device at least 4 hours a night. Conclusions and Relevance: Upper airway stimulation was able to be safely performed for 42 adolescents who had Down syndrome and persistent severe OSA after adenotonsillectomy with positive airway pressure intolerance. There was an acceptable adverse event profile with high rates of therapy response and quality of life improvement. Trial Registration: ClinicalTrials.gov Identifier: NCT02344108.

Initial experience using propranolol as an adjunctive treatment in children with aggressive recurrent respiratory papillomatosis.

We performed a retrospective chart review with a 6-month follow-up to examine the initial use of propranolol as an adjunctive treatment in children with severe recurrent respiratory papillomatosis. This is the first such report. Two of 3 children with severe recurrent respiratory papillomatosis demonstrated a response to oral propranolol therapy, as evidenced by an improved voice and by an increased time between surgical interventions. One child demonstrated no response to propranolol, and medication was halted. Both children who demonstrated a response had undergone more than 10 surgical interventions in the previous year, along with prior treatment including surgical excision and adjuvant therapy. Both children more than doubled the interval between treatments after propranolol administration, and the parents of both children noted marked improvement of the child's voice as measured by their Pediatric Voice-Related Quality of Life score (from 40 to 67.5 in one child and from 27 to 60 in the other child). No child experienced hypoglycemia or blood pressure abnormalities. We conclude that initial use of propranolol as an adjunctive measure in severe recurrent respiratory papillomatosis shows it to have some efficacy in delaying surgical intervention and improving voice. Previous reports have demonstrated relatively safe use of propranolol in children with hemangiomas. Further studies are needed to determine the long-term effectiveness, dosing strategies, and side-effect profile of propranolol for treatment of recurrent respiratory papillomatosis.