Randomised controlled trial of early surgery versus watchful waiting for glue ear: the effect on behavioural problems in pre‐school children

This trial was designed to compare early surgery with watchful waiting for persistent bilateral otitis media with effusion (OME) in terms of hearing loss and behavioural problems in pre‐school children. A randomised controlled trial compared the effects of early treatment with ventilation tubes versus watchful waiting for 9 months. Results were analysed by intention‐to‐treat. One hundred and eighty‐two pre‐school children (date of birth between 1 April 1991 and 31 December 1992), mean age of 2.9 years ( sd 0.85) with at least a 3‐month history of bilateral OME and hearing loss of greater than 25 dB were treated in Bristol Children's Hospital between November 1993 and January 1996. Bilateral ventilation tubes were inserted within 6 weeks of randomisation or within 6 weeks of reassessment after 9 months of watchful waiting, with a final assessment at 18 months. The main outcome measures were behavioural problems, measured by the Richman Behaviour Checklist, and hearing loss at 4000 Hz in the better hearing ear. Early surgical intervention significantly reduced behavioural problems by 17% (95% CI, 2%–33%). This difference was largely mediated by concurrent hearing loss. After 18 months, there was no longer a significant difference (95% CI, −19% to +10%). However, the majority (85%) of the Watchful Waiting group had required surgery and 22% of all children still had behavioural problems.     

The Yoruba version of LittlEARS Auditory Questionnaire: Evaluation of auditory development in children with normal hearing

The goal of this study was to translate the LittlEARS Auditory Questionnaire into Yoruba language for use with Yoruba-speaking parents and to evaluate the psychometric properties of the Yoruba version of questionnaire. Translation of the LittlEARS Auditory Questionnaire into Yoruba language was done using a back-translation method. The study participants included 423 parents of normal hearing children aged 6–24 months. Psychometric analyses (scale analysis and item analysis) of the translated questionnaire was done. The scale characteristics in the dataset are: Internal consistency: Cronbach's alpha?=?0.907; reliability; Split-half?=?0.701; predictive accuracy; Guttman's lambda?=?0.583; correlation between total score and children's age?=?0.783. The regression analysis showed that 75.3% of the variance in the total scores can be explained by age. The Yoruba version of the LittlEARS Auditory Questionnaire is a dependable and valid tool as evidenced by the results of psychometric analyses. The tool is useful for assessing auditory development in children between 6 and 24 months of age.     

A new device for treatment of persistent otitis media with effusion

Objectives

Most children suffer from otitis media with effusion (OME) before starting school. Insertion of grommets into the eardrum for treatment of OME is one of the most common operations performed in childhood. The efficiency and compliance of treatment with a new non-invasive device was evaluated in children with bilateral OME with disease duration of at least 3 months.

Methods

A device for autoinflation was developed to enable a combined modified Valsalva and Politzer maneuver. Ten children, aged 3–8 years (mean: 5 years and 2 months) with OME tested the device for estimation of its ability to ventilate the middle ear. Another thirty-one children, with persistent bilateral OME for at least three months, were divided into a treatment and a control group. Twenty-one children (42 ears), aged 2–7 year (mean: 4 years and 6 months), participated as the treatment group and ten patients (20 ears), aged 3–7 years (mean: 4 years and 5 months), were included as controls. Tympanometry and otomicroscopy were performed at inclusion and at the end of the study.

Results

In the treatment group the middle ear pressure was normalized in 52% and improved in 31% of the ears with 7 children (33%) achieving bilateral and 8 (38%) unilateral normalization. In the control group the middle ear pressure was normalized in 15%, improved in 15% and deteriorated in 10% of the ears with one child (10%) achieving bilateral and one child (10%) unilateral normalization. Statistically significant differences (p < 0.001) were observed in the pressure difference and the tympanometry type changes between the treatment and the control group. Otomicroscopic examination revealed that the number of ears judged as OME was reduced by 62% in the treatment group in comparison with 20% in the control group. All children managed to perform the maneuver and no side effects were neither reported nor detected.

Conclusions

The device was efficient in ventilation of the middle ear with normalization or improvement of the negative middle ear pressure and otomicroscopic findings in young children with persistent OME.     

External validation of the LittlEARS® Auditory Questionnaire with English-speaking families of Canadian children with normal hearing

Objective

To examine the external validity of the United Kingdom English version of the LittlEARS^® Auditory Questionnaire with English-speaking families of Canadian children with normal hearing.

Methods

The United Kingdom English version of the LittlEARS was administered to English-speaking families of 130 children with normal hearing in Ontario, Canada. Total scores for these children were compared to German-derived normative values.

Results

There was no significant difference between Canadian and German norms when using the United Kingdom English version of the LittlEARS Auditory Questionnaire.

Conclusions

The United Kingdom English version of the LittlEARS Auditory Questionnaire is appropriate for use with English-speaking families of normal hearing Canadian children.     

The endothelial nitric oxide synthase (eNOS) polymorphism in otitis media with effusion (OME)

Objectives

Otitis media with effusion (OME) is the most common disease after viral infections of upper respiratory tract (URTI) in children. Studies indicate the important role of nitric oxide (NO) in the etiology of hearing loss. However, there is no study that focuses on the role of nitric oxide synthase (eNOS) polymorphisms in the cases with OME. The aim of the present study is to evaluate the eNOS polymorphisms in the pediatric patients with OME.

Middle ear problems in children hospitalised because of lower respiratory tract infections: A comparison between two cohorts in Burundi and Italy

Objectives

To compare the prevalence of acute otitis media (AOM) and otitis media with effusion (OME) in children hospitalized for acute lower respiratory infections (LRTIs) in Burundi and Italy.

Methods

The study, which was conducted from 1 February to 30 April 2011 at the hospital of Kiremba (Burundi, Africa) and at Paediatric Clinic 1 of the University of Milan (Italy), enrolled patients aged <5 years who were hospitalised because of LRTIs. Upon admission, the children underwent an otological examination (pneumatic otoscopy and tympanometry), and middle ear diseases were compared between the two groups.

Results

A total of 108 children enrolled in Burundi (44 males; median age 17 months) were compared to 108 patients enrolled in Italy (53 males; median age 19 months). About one-third of the children in Burundi (33, 30.6%) had normal middle ears. AOM was never diagnosed, whereas OME was detected in 74 children (68.5%: bilateral in 51, 68.9%, and unilateral in 23, 31.1%). The prevalence of OME decreased with increasing age: it was 86.5% in children aged <12 months, 73.7% in those aged 12–24 months, and 43.8% in those aged >24 months (p < 0.001). There was no difference in the proportion of children with OME in Burundi (68.5%) and Italy (63.9%; p = 0.47). OME was significantly more frequent in the children with pneumonia admitted in Burundi than in the children with pneumonia admitted in Italy (p = 0.004).

Conclusions

In children hospitalized for lower respiratory tract infection, OME is almost as frequently seen in developing countries like Burundi, Africa, as in developed countries like Italy. Follow-up monitoring of these children might be required to assess if OME is just a transient phenomenon.     

Sequelae of otitis media with effusion among children with cleft lip and/or cleft palate1

Otitis media with effusion (OME) is common among children with cleft palate, and may lead to such long‐term consequences as hearing loss, tympanic membrane retraction, and chronic otitis media (COM). In total, 104 children with cleft lip and/or palate treated for OME at our institution were reviewed. Mean duration of follow‐up was 6.9 years, and mean age at latest follow‐up was 9.6 years. The incidence of COM was 19%, and the incidence of cholesteatoma was 1.9%. Ears showing such long‐term sequelae of OME as hearing loss, tympanic membrane retraction, and chronic otitis media, were noted to have undergone a significantly greater number of ventilation tube insertions than ears not showing these sequalae. Our findings would suggest that a conservative approach to the management of OME in children with cleft palate is more likely to be beneficial in the long term.     

Expression of aquaporins mRNAs in patients with otitis media

Objective: This study analyzed the associations between measured levels of aquaporin (AQP) mRNAs and clinical manifestations in patients with various types of otitis media (OM).

Methods: AQP1, 2, 3, 4, 5, 6, 8, and 10 mRNA levels were assayed by real-time PCR from 57 patients with chronic otitis media (COM), 24 patients with cholesteatomatous otitis media (choleOM), and 82 patients with otitis media with effusion (OME). The relationships of these mRNA levels with the presence of bacteria, the type of hearing loss, and clinical manifestations of OM types were evaluated.

Results: All eight AQP mRNAs were expressed in inflammatory tissue, chole matrix, and effusion fluid obtained from all 163 patients with OM. The levels in OME of AQP2, 4, 6, and 10 mRNA; and the levels in choleOM of AQP1, 3, 4, and 10 mRNA were elevated significantly compared to the corresponding levels in COM (p?p?Conclusions: The levels of expression of AQP mRNA are associated with the pathophysiology of OM.     

Is facial pattern a predisposing factor for otitis media with effusion in children?

Abnormalities in craniofacial morphology are associated with Eustachian tube dysfunction and otitis media with effusion (OME).Aim: to evaluate the relationship between facial pattern and craniofacial growth direction, and OME in children with enlarged tonsils and adenoids (ETA).Methods: Clinical prospective survey in 79 children (41 male and 38 female), ranging from 4 to 10 years of age, with tonsil and adenoid enlargement (Brodsky's grades III and IV). Forty children presented with OME (study group) and 39 did not (control group). Cephalometric analysis was used to determine the facial pattern.Results: There was no correlation observed between facial pattern and OME (c 2 = 0.25 p = 0.88). Facial Axis was larger in the OME group (F(1.75) = 3.68 p = 0.05) and the Lower Anterior Facial height was smaller (F(1. 75) = 3.99 p = 0.05) in children with otitis media with effusion.Conclusions: There was no correlation between OME and facial pattern in children with ETA although a more horizontal facial growth direction, and a smaller lower anterior facial height was observed consistently among subjects in this group. This suggests that abnormal positioning of the eustachian tube influences the development of OME in children with ETA.     

The natural course of otitis media with effusion in preschool children

Summary In order to gain an insight into the natural course of otitis media with effusion (OME), a prospective study was carried out on 1328 children out of a cohort of 1439 preschool children. These children were seen in follow-up for their OME every 3 months, at which times tympanometry was performed. The results show a fairly constant rate of improvement of about 50% every 3 months. The cumulative rate of recurrence of OME was about 50% in the study period. Two-thirds of all OME with flat tympanograms had a duration of less than 3 months. Some factors could be identified as having an effect on the natural history of OME. The season and patients' age and sex were found to be associated with the duration and the recovery rate. Risk factors for recurrences were the same as those already reported in the literature.     

Clinical evaluation of pepsin for laryngopharyngeal reflux in children with otitis media with effusion

Objective

We sought to evaluate the clinical role of pepsin for laryngopharyngeal reflux (LPR) in children with otitis media with effusion (OME).

Methods

Pepsin/pepsinogen and fibrinogen were analyzed in fifty effusion and blood samples of children with OME using enzyme linked immunosorbent assay (ELISA). Ambulatory 24-h dual-probe pH monitoring was additionally performed in 31 children divided into two groups according to response of medical treatment.

Results

The effusion levels of pepsin/pepsinogen ranged from 8.5 to 1512 μg/dl and were up to 4–540 times higher than the concentrations found in plasma samples. The effusion levels of fibrinogen ranged from 0.05 to 4.1 g/dl. Some effusion samples showed fibrinogen concentrations did not exceed 10 times higher than the concentrations found in plasma samples and others showed lower concentrations. The pH of effusion samples was 7.13 to 8.72. Dual-probe pH monitoring showed that 22/31 (71%) of the studied children had significant acid reflux documented by either the esophageal probe or the pharyngeal probe and all of them had LPR. There is a significant positive correlation between the level of pepsin assayed in the effusions and the number of pharyngeal reflux episodes measured by pH monitoring.

Conclusions

Analysis of pepsin/pepsinogen in effusion samples of children with OME, using ELISA, can be considered as a reliable biochemical marker for assessment of laryngopharyngeal reflux.     

Dendritic cells and lymphocyte subpopulations of the adenoid in the pathogenesis of otitis media with effusion

Objective

To assess dendritic cells and lymphocyte subpopulations of adenoid and peripheral blood in patients with adenoid hypertrophy and otitis media with effusion (OME). To explain the influence of immunological status of adenoid on the development of OME.

Methods

The examined group covered 123 surgically treated patients due to adenoid hypertrophy (39 children with coexisting OME). Preoperative clinical examination included anamnesis and otorhinolaryngological examination with nasofiberoscopy, videootoscopy and assessment of the hearing organ. The material of the study were surgically removed adenoids and peripheral blood samples prepared and then analyzed by the means of tri-colour flow cytometry. The obtained results were statistically analyzed.

Results

Significant differences between patients with adenoid hypertrophy with coexisting OME and children without OME concerning CD19+CD69+, CD3+CD69+, CD4+CD69+CD8+CD69+ and CD19+CD25+ cells were observed. No statistical differences were revealed in the blood of patients with and without OME. Several statistical differences were noted between the adenoid and peripheral blood in patients with otitis media with effusion concerning BDCA-2+/CD123+ cells, CD3+ and CD19+ lymphocytes with the markers of their activation.

Conclusions

The adenoid is involved in local immune response regardless of constitutional immunological mechanisms in patients with OME coexisting with adenoid hypertrophy. Significantly lower percentage of CD3+CD69+, CD4+CD69+, CD8+CD69+ and CD19+CD69+ cells of adenoid in patients with OME attests to reduced T-cells activation of the adenoid in relation to patients without OME.     

PERSISTENCE OF MIDDLE EAR DYSFUNCTION AFTER RECURRENT ACUTE OTITIS MEDIA

The presence of otitis media with effusion (OME) and high negative pressure (-200 to -400 mm H₂O)₃ were investigated in follow-up of a randomized double-blind placebo-blind placebo-controlled trial on the efficacyu of amoxicilin/clavulanic acid in the treatment of acute otitis media. All children in this study were recruited from a general practice population. Tympanometry results 1 month from the start of an episode of acute otitis media were taken as outcome criteria. Bilateral middle ear dysfunction was defined as bilateral OME, unilateral OME and contralateral or bilateral high negative pressure. Bilateral middle ear dyusfunction was present in 47.9% of the patients. Of all teh investigated factors of possible influence (age, sex, season, laterality of acute otitis media, therapy, and clinical course of acute otitis media), only season showed a statistically significant influence on the persistence of OME/high negative pressure (P = 0.001). Bilateral middle ear dysfunction was shown to be of prognostic value for the risk of a recurrence of acute otitis media (odds ratio 3.75). shown to be of prognostic value for the risk of a recurence of acute otitis media (odds ratio 3.75).     

Clinical approaches for understanding the expression levels of pattern recognition receptors in otitis media with effusion

Objectives

Bacterial infections in the normally sterile environment of the middle ear cavity usually trigger host immune response, whereby the innate immune system plays a dominant role as the host''s first line of defense. We evaluated the expression levels of Toll-like receptors (TLRs) -2, -4, -5, -9, and nucleotide-binding oligomerization domain-containing proteins (NODs) -1 and -2, all of which are related to bacterial infection in pediatric patients with otitis media with effusion (OME).

Methods

The study sample consisted of 46 pediatric patients with OME, all of whom had ventilation tubes inserted. The expression levels of TLR-2, -4, -5, -9, NOD-1 and -2 mRNA in middle ear effusion were assessed by polymerase chain reaction (PCR). Difference of pattern recognition receptors (PRRs) expression level by presence of bacteria, ventilation tube insertion rate, and effusion fluid character was assessed.

Results

All effusion fluid samples collected from patients with OME showed expression of TLR-2, -4, -5, -9, NOD-1, and -2 mRNA by PCR. However, we found no differences among expression levels of PRRs in relation to characteristics of exudates, presence of bacteria, or frequencies of ventilation tube insertion (P>0.05).

Conclusion

Our findings suggest that exudates of OME patients show PRR expressions that are related to the innate immune response regardless of the characteristics of effusion fluid, presence of bacteria in exudates, or frequency of ventilation tube insertion.     

The point prevalence of otitis media with effusion in secondary school children in Pokhara,Nepal: A cross-sectional study

Objective

Otitis media with effusion (OME) is a condition of uncertain aetiology seen in paediatric practice. It has important sequelae that can result in significant morbidity. Worldwide documentation of OME prevalence in older children is poor as OME is traditionally seen in children below the age of 6 years. Available research in Nepal reports a prevalence of OME in children between the ages of 3 and 8 years as high as 27%. This study aims to establish a reliable prevalence of OME in children between the ages of 9 and 16 years in order to inform public health policy and target limited resources.

Methods

This cross-sectional study was undertaken in Pokhara, Nepal. Two different school populations were examined, government and non-government. Children in these schools between 9 and 16 years underwent clinical assessment for OME with otoscopy and tympanometry. Demographic data were also collected to identify potential OME risk factors. For each school population the prevalence of unilateral, bilateral and all case OME was calculated as percentages with 95% confidence intervals.

Results

A total of 494 children were recruited in this study (government = 187, non-government = 307). Fourteen were excluded due to impacted cerumen or other ENT pathology making it very difficult to conduct a clinical assessment. In the combined school populations the point prevalence of OME was 12.9%. The peak prevalence of OME was found in children aged 10 years (23.1%). A higher point prevalence of OME was found in the non-government school population than the government school (government = 9.3%, non-government = 15.0%). This difference was not statistically significant (χ² = 3.209, df = 1, p = 0.073). Age was found to be significant predictor of OME.

Conclusions

Contrary to its established natural history OME has been found to be widespread in older children in Nepal. No significant predictors of OME were established and rates did not vary significantly between school types. Studies need to be conducted in a larger population to investigate this further. To fully assess disease burden of OME amongst children in Nepal, prevalence in children not regularly attending schools also needs investigation.     

Effect of Nebulized Bovine Surfactant for Experimental Otitis Media with Effusion

Objectives

In this study, we evaluated the efficacy of nebulized bovine pulmonary surfactant on experimentally induced otitis media with effusion (OME) in guinea pigs.

Methods

Twenty guinea pigs were divided into three groups. Four untreated animals served as normal controls. Experimental OME was established in both ears of the remaining 16 animals by a transbullar injection of 10 µL of Pseudomonas aeruginosa lipopolysaccharide in saline. Thereafter, the guinea pigs received nebulized phosphate buffered saline (n=8) or nebulized bovine pulmonary surfactant (n=8). Nebulization was given daily for 7 days. On day 8, all the animals'' passive opening pressure (POP) of the Eustachian tube was measured and histopathological observations of the bulla were made by light microscopy.

Results

Nebulized bovine pulmonary surfactant significantly reduced the POP compared to that of saline nebulization. The bovine pulmonary surfactant improved the tubal patency and produced less histopathologcally-evident edematous bullar mucosa.

Conclusion

Nebulization of bovine pulmonary surfactant plays an important role in treating otitis media with effusion in guinea pigs. Our results suggest that the chosen nebulized bovine pulmonary surfactant can be of good clinical benefit for treating OME in the future.     

Management for the Children with Otitis Media with Effusion in the Tertiary Hospital

Objectives

Recently, new evidence-based recommendations have been introduced for diagnosing and managing otitis media with effusion (OME) in children. However, there are some difficulties to follow the general guidelines in the tertiary hospitals. The purpose is to evaluate the efficiency of antibiotics or antihistamines for treatment of children with OME in the tertiary hospital with a randomized prospective clinical study.

Methods

Eighty-four children with OME who had been diagnosed in the tertiary hospital were randomized to receive 5 different medications for 2 weeks. We prescribed antibiotics (amoxicillin-clavulanate syrup) in Group I (n=16), antibiotics/steroids (prednisolone) in Group II (n=18), antibiotics/antihistamines (ebastine) in Group III (n=15), antibiotics/steroids/antihistamines in Group IV (n=17), and mucolytics (ivy leaf extract) in Group V (n=17) for control. We followed-up children every 2 weeks and evaluated the state of OME at 3 months.

Results

Thirty six (42.9%) of 84 children were resolved within average 6.9 weeks after the treatments. Thirty-six (42.9%) were treated with ventilation tube insertion and 12 patients (14.3%) were observed. There was no difference in the resolution rates of OME among the five different protocols (P>0.05). There was no difference in the resolution rates among groups who used steroids, antihistamines, steroids and antihistamines, or other medications to manage 42 children with allergies (P>0.05).

Conclusion

In the tertiary hospital, the cure rate of children with OME was not as high as well-known, and antibiotics or anti-allergic medications were not more effective than control. We may, therefore, need any other guidelines which are different from the previous evidence-based recommendations, including early operation in the tertiary hospitals.     

Adenoidectomy With Laser or Incisional Myringotomy for Otitis Media With Effusion

Objective To compare the effectiveness of CO₂ laser myringotomy to incisional myringotomy at the time of adenoidectomy for refractory otitis media with effusion (OME). Study Design Controlled retrospective consecutive case series. Methods All children undergoing myringotomy and adenoidectomy for OME in the spring of 1999 had 1.7‐mm‐diameter perforations created in their tympanic membranes using a CO₂ laser and conventional microslad. Their ears were evaluated at first postoperative visit (mean, 16.65 days after surgery) by a validated otoscopist to determine the presence or absence of perforations and middle ear effusions. These patients were compared with historical controls comprising all children undergoing incisional myringotomy and adenoidectomy in 1998. A χ² analysis was performed to compare the results of these two myringotomy techniques. Results Twenty‐three children (39 ears) underwent laser myringotomy and adenoidectomy in 1999, compared with 26 children (48 ears) who underwent incisional myringotomy and adenoidectomy in 1998. In the laser myringotomy group, 8 of the 39 ears had a persistent opening at first follow‐up; 4 of the 39 ears showed evidence of effusion. In the incisional myringotomy group, all 48 ears had healed; 7 of these ears showed evidence of effusion. Conclusion Myringotomies created using the CO₂ laser are more likely to be patent at first postoperative visit than those made with incisional technique (P < .01). However, this prolonged middle ear ventilation does not significantly decrease the prevalence of effusion (P > .1).