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Acute rhinosinusitis (ARS) in children may be accompanied by acute otitis media (AOM) which is often associated with bacterial co-infections. These conditions are among the primary reasons that children visit hospitals and require antibiotic treatment. This study evaluated the efficacy of the nasal-spraying probiotics (LiveSpo Navax containing 5 billion Bacillus subtilis and B. clausii spores/5 mL) as a supportive treatment for dual ARS and AOM with otorrhea in a randomized, single-blind, controlled clinical trial. Eighty-two patients (41 per group), aged 1 month to 12 years, received standard care along with nasal spraying of either physiological saline (Control group) or LiveSpo Navax (Navax group), administered three times daily over a 7-day follow-up period. A total of sixty-one patients (30–31 per group) completed the trial. The Navax group experienced 68.00% and 96.77% reductions in nasal congestion (by day 3) and rhinorrhea (by day 7), respectively, which were 2.04 and 1.94-fold higher than the Control group, with odds ratios (OR) of 4.31 and 30.00 ( p  < 0.05). Endoscopic results indicated 8% and 11% higher reductions in nasal mucopurulent discharge and tympanic membrane hyperemia in the Navax group compared to the Control group. By day 3, compared to day 0, the Navax group exhibited > 1200-fold reduction in Streptococcus pneumoniae and ≥ 4-fold reduction in Haemophilus influenzae concentrations ( p  < 0.05) in both nasopharyngeal and middle ear fluid samples, whereas the Control group showed no significant reductions. Navax treatment reduced IL-6 by 1.35- to 1.74-fold and TNF-α by 1.17- to 1.45-fold, more effectively than the Control group ( p  < 0.05). These results suggest that nasal-spray Bacillus spore probiotics, with their ability to reduce bacterial load and modulate immune responses, provide a cost-effective and safe solution for alleviating symptoms of both ARS and AOM in children. Trial registration : ClinicalTrials.gov, Identifier NCT05804123 on April 7, 2023.

The objectives of this study were to ascertain the feasibility of transcanal endoscopic underlay myringoplasty using temporalis fascia and compare the results with microscopic myringoplasty. This prospective randomized trial included 60 patients with mucosal chronic otitis media with tympanic membrane perforations of all sizes and locations apart from posteriorly based small or moderate sized perforations. In the endoscopy group, 30 patients underwent exclusive transcanal myringoplasty using tympanomeatal flap elevation with underlay graft placement. In the microscopy group, 30 patients underwent myringoplasty using the postaural approach. Intra-operative variables compared were canalplasty and canal wall curettage for assessment of ossicular status. Graft uptake, hearing outcomes using pure tone audiometry and subjective cosmetic outcomes were assessed 24 weeks post-operatively and compared in the two groups. Resident feedback on the feasibility of endoscopic myringoplasty was obtained using a questionnaire. In the microscopy group, 5/30 patients required canalplasty due to canal overhangs and 4/30 required canal wall curettage for ossicular assessment, whereas none of the patients in the endoscopy group required these procedures. A graft uptake rate of 83.3 % was observed in both groups post-operatively after 24 weeks. Mean air-bone gap pre- and post-operatively in the endoscopy group was 28.5 and 18.13 dB, respectively, whereas these values were 32.4 and 16.9 dB, respectively, in the microscopy group. Subjective cosmetic outcomes were better in the endoscopy group. Resident feedback on endoscopic myringoplasty was positive. Endoscopic myringoplasty appears to be an effective alternative to microscopic myringoplasty and results in excellent hearing with good cosmetic outcomes.

The aim of this study was to compare the audiologic outcomes of the patients who underwent endoscopy on one ear and microscopic tympanoplasty on the other, and to investigate the operative time, graft success, postoperative pain and health status. This prospective randomized controlled study was carried out in Ege University ENT Department between February 2015 and September 2016. The patients who had bilateral chronic otitis media, normal middle ear mucosa and a hearing loss difference of 10 dB or less between the two ears randomly underwent microscopic tympanoplasty in one ear and endoscopic tympanoplasty in the contralateral ear, with 6-month intervals. 13 patients were included in the study with a mean age of 36.17 ± 3.61 years (range 17–53 years, 7 female, 6 male). The improvement in air–bone gap for groups 1 (endoscopic) and 2 (microscopic) was 9.48 ± 5.23 and 9.89 ± 2.79 dB, respectively. The duration of the surgery in group 1 was significantly lower than that in group 2 ( p  < 0.01). VAS scores were 2.15 ± 0.37 and 3.76 ± 1.64 cm for groups 1 and 2, respectively ( p  = 0.006). The endoscopic approach for type 1 tympanoplasty offers shorter surgery time, better health status and lower postoperative pain than microscopic surgery. In addition, endoscopic surgery offers comparable improvement in air–bone gap and similar graft success. The endoscopic approach has comparable audiological and morphological graft outcomes with the microscopic one. The endoscopic approach yielded better health and pain status for the same patients. Level of evidence This is an individual randomized controlled trial. The level of evidence is 1b.

BACKGROUND: Acute mastoiditis (AM), a complication of acute otitis media, remains a concern despite medical advancements and often leads to severe complications such as cerebral sinus vein thrombosis (CSVT). This study aimed to characterize the clinical, microbiological, and hemato-logical aspects of CSVT secondary to AM in children while assessing the necessity of thrombophilia evaluation in these patients. METHODS: A retrospective analysis was conducted on pediatric patients with CSVT secondary to AM between January 2015 and December 2022. This study examined clinical data, laboratory and microbiological results, imaging studies, treatment approaches, and patient outcomes. RESULTS: Seventeen pediatric patients with a mean age of 3 years were included in this study. Most patients were female (76.5%) and of Jewish ethnicity (82.4%). Group A Streptococcus is the primary pathogen responsible for this condition. The treatment plan involved the administration of intravenous antibiotics and surgical intervention, including cortical mastoidectomy and ventilation tube insertion. Additionally, anticoagulation therapy with Clexane[R] was initiated and continued for at least 3 months post event. Follow-up imaging revealed recanalization in most cases within an average of 3 months. Hematologic follow-up revealed no recurrent thrombotic events and low thrombophilia incidence. CONCLUSION: Cerebral sinus vein thrombosis following AM is a provoked thrombotic event effectively managed with Clexane[R]. Thrombophilia evaluation may be reserved for patients with a high suspicion of underlying hematological conditions. Follow-up imaging within 3 months post event may be premature. KEYWORDS: Acute mastoiditis, anticoagulation therapy, cerebral sinus vein thrombosis, thrombophilia

Background Whilst current guidelines highlight the importance of pain management for children with acute otitis media (AOM), there is evidence to suggest that this is not implemented in everyday practice. We have developed a primary care-based multifaceted educational intervention to optimise pain management in children with AOM, and we trial its clinical and cost effectiveness. Methods This cluster randomised controlled trial aims to recruit 250 children aged 6 months to 10 years presenting with AOM to general practitioners (GPs) in 30 primary care centres (PCCs) across the Netherlands. GPs in the PCCs allocated to the intervention group receive a blended GP educational programme (online and face-to-face training). The intervention asks GPs to proactively discuss pain management with parents using an information leaflet, and to prescribe paracetamol and ibuprofen according to current guidelines. GPs in both groups complete an online module illustrating various otoscopic images to standardise AOM diagnosis. GPs in the PCCs allocated to the control group do not receive any further training and provide ‘care as usual’. During the 4-week follow-up, parents complete a symptom diary. The primary outcome is the difference in parent-reported mean earache scores over the first 3 days. Secondary outcomes include both number of days with earache and fever, GP re-consultations for AOM, antibiotic prescriptions, and costs. Analysis will be by intention-to-treat. Discussion The optimal use of analgesics through the multifaceted intervention may provide symptom relief and thereby reduce re-consultations and antibiotic prescriptions in children with AOM. Trial registration Netherlands Trial Register, NTR4920 . Registered on 19 December 2014.

ObjectivesThis systematic review summarises the evidence on the correlation between recurrent acute otitis media (rAOM) or chronic suppurative otitis media (CSOM) and sensorineural hearing loss (SNHL).Research methodsPubMed, Embase and Cochrane Library databases were searched from inception to 15 January 2021. Two authors independently identified articles, extracted data and performed quality assessment for included studies. Studies comparing the sensorineural hearing levels of patients with a history of rAOM/CSOM for >3 months to a control group were included.ResultsScreening of 4168 articles lead to inclusion of two case-control studies (control-group: patients non-OM) and seven cohort-studies (control group: contralateral ear). Quality assessment indicated considerable risk of bias in all studies. Reported populations varied (sample size 13–607, mean age 22–41.5 years, mean duration of disease 6.1–12.4 years). The OR for SNHL in the OM-group was 3.30–7.86 (95% CI 1.16 to 9.40, p<0.05) in cohort studies (n=2), and 0.05 (95% CI 0 to 0.78, p<0.05) in a case-control study. Mean/median bone conduction thresholds were respectively 1.19–32.21/0–10 dB higher on all frequencies (0.5–4 kHz) for the OM-group in four cohort studies (p<0.05). Two other studies reported no statistical test outcomes.ConclusionDue to the high risk of bias of included studies, effect estimates heterogeneity and suboptimal research designs, no conclusion on the correlation between OM and SNHL can be made. It emphasises the need for future prognostic studies.

To investigate hearing and the take rate of crushed cartilage grafts in tympanoplasty. In this double-blinded, randomised, controlled trial, 46 patients with tympanic membrane perforation were enrolled. A conchal cartilage graft was used for reconstruction in both intervention and control groups. In the intervention group, crushed cartilage was used. The success rate and hearing results were ascertained every four months over a one-year follow-up period. A total of 36 patients - 20 in the intervention group and 16 in the control group - completed one year of follow up. There were no statistically significant differences between the two groups in mean air-bone gap, bone conduction threshold, speech discrimination score or speech reception threshold. The reduction in living cells after crushed cartilage tympanoplasty may decrease the rigidity and the volume of the graft, but may not necessarily improve the hearing results.

Debate continues with respect to a \"watch and wait\" approach versus immediate antibiotic treatment for the initial treatment of acute otitis media. In this double-blind noninferiority trial, we compared clinical improvement rates at 14 days for children (6 months to 5 years of age) with acute otitis media who were randomly assigned to receive amoxicillin or placebo. We enrolled healthy children who presented to clinics or the emergency department with a new episode of acute otitis media during the fall and winter months in Ottawa (from December 1999 to the end of March 2002). The children were randomly assigned to receive amoxicillin (60 mg/kg daily) or placebo for 10 days. Telephone follow-up was performed on each of days 1, 2 and 3 and once between day 10 and day 14. The primary outcome was clinical resolution of symptoms, defined as absence of receipt of an antimicrobial (other than the amoxicillin in the treatment group) at any time during the 14-day period. Secondary outcomes were the presence of pain and fever and the activity level in the first 3 days, recurrence rates, and the presence of middle ear effusion at 1 and 3 months. According to clinical scoring, 415 of the 512 children who could be evaluated had moderate disease. At 14 days 84.2% of the children receiving placebo and 92.8% of those receiving amoxicillin had clinical resolution of symptoms (absolute difference -8.6%, 95% confidence interval -14.4% to -3.0%). Children who received placebo had more pain and fever in the first 2 days. There were no statistical differences in adverse events between the 2 groups, nor were there any significant differences in recurrence rates or middle ear effusion at 1 and 3 months. Our results did not support the hypothesis that placebo was noninferior to amoxicillin (i.e., that the 14-day cure rates among children with clinically diagnosed acute otitis media would not be substantially worse in the placebo group than the treatment group). Nevertheless, delaying treatment was associated with resolution of clinical signs and symptoms in most of the children.

Purpose Chronic otitis media with effusion (COME) is a common condition in children and a leading cause for hearing loss and ventilation tubes (VT) insertion. Among other risk factors, it is suggested that Helicobacter pylori ( H. pylori ) infection may have a role in the pathogenesis of COME. Previous studies have reached different results, and therefore, there is a need for further data on the relationship between H. pylori infection and COME development in children. Our objective is to investigate the presence of H. pylori in the middle-ear fluid (MEF) from children with COME. Methods A Comparative cross-sectional study. Children ≤ 18 years were included. The study group included children diagnosed with COME and required VT insertion. The control group included children with acute otitis media (AOM) who required myringotomy in the emergency room. Middle-ear fluid samples were sent for both culture and bacterial identification using polymerase chain reaction (PCR) testing. Results A total of 43 children were included. Eighteen with COME (median age 4 years, IQR 3–6), and 25 with AOM (median age 1 year, IQR 1–2). All samples were cultured for H. pylori . Twenty-two samples underwent H. pylori PCR testing of them, 12 samples from children with COME, and 10 from children with AOM. All cultures and PCR tests results were negative for H. pylori . Conclusions Our results suggest that H. pylori does not have a role in the pathogenesis of COME. Future larger studies are needed to investigate whether H. pylori has a role in the pathogenesis of COME.

Background Aboriginal children in remote Australia have high rates of complicated middle ear disease associated with Streptococcus pneumoniae and other pathogens. We assessed the effectiveness of pneumococcal vaccination for prevention of otitis media in this setting. Methods We compared two birth cohorts, one enrolled before (1996–2001), and the second enrolled after introduction of 7-valent pneumococcal conjugate and booster 23-valent polysaccharide vaccine (2001–2004). Source populations were the same for both cohorts. Detailed examinations including tympanometry, video-recorded pneumatic otoscopy and collection of discharge from tympanic membrane perforations, were performed as soon as possible after birth and then at regular intervals until 24 months of life. Analyses (survival, point prevalence and incidence) were adjusted for confounding factors and repeated measures with sensitivity analyses of differential follow-up. Results Ninety-seven vaccinees and 51 comparison participants were enrolled. By age 6 months, 96% (81/84) of vaccinees and 100% (41/41) of comparison subjects experienced otitis media with effusion (OME), and by 12 months 89% and 88% experienced acute otitis media (AOM), 34% and 35% experienced tympanic membrane perforation (TMP) and 14% and 23% experienced chronic suppurative otitis media (CSOM). Age at the first episode of OME, AOM, TMP and CSOM was not significantly different between the two groups. Adjusted incidence of AOM (incidence rate ratio: 0.88 [95% confidence interval (CI): 0.69–1.13]) and TMP (incidence rate ratio: 0.63 [0.36–1.11]) was not significantly reduced in vaccinees. Vaccinees experienced less recurrent TMP, 9% (8/95) versus 22% (11/51), (odds ratio: 0.33 [0.11–1.00]). Conclusion Results of this study should be interpreted with caution due to potential bias and confounding. It appears that introduction of pneumococcal vaccination among Aboriginal infants was not associated with significant changes in prevalence or age of onset of different OM outcomes or the incidence of AOM or TMP. Vaccinees appeared to experience reduced recurrence of TMP. Ongoing high rates of complicated OM necessitate additional strategies to prevent ear disease in this population.