Epidemiology of otitis media onset by six months of age.

OBJECTIVE: Although early otitis media (OM) onset predicts later recurrent and chronic OM, little research has been directed at illuminating the role of prenatal exposures in early OM. This prospective study examined prenatal, innate, and early environmental exposures associated with acute otitis media (AOM) onset and recurrent OM (ROM) by age 6 months. DESIGN AND METHODS: Prospective study of 596 infants from a health maintenance organization followed from birth to 6 months. Mothers completed monthly forms on prenatal exposures (diet, medications, and illnesses) and infant risk factors (eg, smoke exposure and child care) during pregnancy and until infants were 6 months old. Urine samples were collected when infants were 2 months of age and analyzed for cotinine and creatinine. Physicians and nurse practitioners examined infants at each clinic visit and completed standard ear examination forms. RESULTS: Thirty-nine percent had an episode of AOM and 20% had ROM by age 6 months. Using Cox's regression models to control for confounding, respiratory tract infection (relative risk [RR] 7.5), day care (RR 1. 7), >1 sibling (RR 1.4), maternal, paternal, and sibling OM history (RR 1.6, 1.5, and 1.7, respectively) were significantly related to early OM onset. ROM was related to respiratory tract infection (RR 9. 5), day care (RR 1.9), conjunctivitis (RR 2.0), maternal OM history (RR 1.9), and birth in the fall (RR 2.6). Among prenatal exposures, only high prenatal dietary vitamin C intake was significantly inversely related to early AOM with univariate but not multivariate analysis. CONCLUSION: Prenatal factors were not linked to early AOM onset with multivariate analysis, but environmental and innate factors play an important role in early AOM onset. Strategies to reduce exposure to environmental variables could reduce rates of early AOM, which could potentially result in declining rates of ROM and chronic OME.

The microbiology of serous and mucoid otitis media.

One hundred forty-four serous and mucoid effusions were cultured for aerobic bacteria, Mycoplasma pneumoniae, and virus. Thirty percent of all effusions yielded an unequivocally positive culture for aerobic bacteria. Although serous effusions were culture positive as often as mucoid effusions, Haemophilus influenzae was isolated predominantly from serous effusions and Staphylococcus epidermidis predominantly from mucoid samples. Only one of 73 effusions yielded a viral isolate (Herpesvirus hominis). None of 33 effusions yielded M pneumoniae, and only one of 17 effusions yielded an anaerobe (Propionibacterium). These findings suggest that aerobic bacteria may play a role in the pathogensis of serous and mucoid otitis media.

Serum antibody response to pneumococcal vaccine in children with nephrotic syndrome.

Children with nephrotic syndrome are susceptible to serious pneumococcal disease and may be immunodeficient on the basis of abnormal humoral immune responses to natural antigens or immunoglobulin loss during relapse. As part of an ongoing study to evaluate pneumococcal anticapsular antibody concentration and immunologic competence, 27 steroid-responsive and six steroid-resistant patients with nephrotic syndrome, and 12 age-matched control subjects, were vaccinated with polyvalent pneumococcal vaccine. Antibody responders were defined as patients with at least a twofold increase in antibody after vaccination as well as an antibody concentration greater than 200 ng of anticapsular antibody nitrogen per milliliter (ngN/ml) after vaccination. Pneumococcal antibody concentrations before and after vaccination were significantly depressed in steroid-resistant patients when compared with control subjects (P less than .002) and with the steroid-responsive nephrotic syndrome group (P less then .001). Steroid-responsive nephrotic children who were not receiving corticosteroid therapy at the time of vaccination had significantly higher antibody concentrations to five pneumococcal types before vaccination and to seven types after vaccination compared with control subjects (P less than .05). Fewer steroid-responsive patients receiving corticosteroids achieved antibody concentrations greater than or equal to 200 ngN/ml against type 19F compared with patients not receiving steroids or with control subjects (P less than .05). These results suggest that pneumococcal vaccine is immunogenic in children with steroid-responsive nephrotic syndrome and may protect these patients from disease due to pneumococcal types contained in the vaccine.

Resolution of otitis media with effusion with the use of a stepped treatment regimen of trimethoprim-sulfamethoxazole and prednisone.

This double blind, placebo-controlled trial was designed to determine whether intervention with a stepped regimen of trimethoprim-sulfamethoxazole (TMP-SMX) and prednisone would prevent high risk children from developing chronic otitis media with effusion (OME) and recurrent acute otitis media. Forty-two children were enrolled, assigned to treatment with active drug or placebo and then examined at 2-week intervals. They received TMP-SMX (or placebo) during the first 2 weeks, TMP-SMX and prednisone (or placebo) during Weeks 3 and 4 for persistent OME and TMP-SMX (or placebo) for Weeks 5 and 6 if OME was still unresolved. After treatment 48% of active drug and 14% of placebo subjects resolved OME bilaterally (P less than 0.05). Active drug subjects also had fewer acute otitis media episodes than placebo subjects while receiving study treatment (P less than 0.01). Although this treatment regimen produced short term OME resolution, long term benefits were not demonstrated.

Amoxicillin middle ear fluid penetration and pharmacokinetics in children with acute otitis media.

BACKGROUND: Acute otitis media (AOM) is a common childhood infectious disease. The efficacy of antibiotic dosing regimens is usually assessed by antibiotic plasma pharmacokinetics or middle ear fluid (MEF) concentration at one or two time points. Viral coinfection in AOM reduced antibacterial efficacy of antibiotics. OBJECTIVE: To determine amoxicillin MEF penetration and pharmacokinetics in bacterial and combined bacterial and viral AOM. METHODS: Thirty-four children with AOM were enrolled, and MEF was collected by tympanocentesis for bacterial culture and viral studies. Nasal wash and venous blood were also obtained for viral culture and serologic studies, respectively. Subjects were treated with amoxicillin 40 mg/kg/day orally, divided in equal doses every 8 h. During the second visit (48 to 72 h later) the subjects, with the regular morning amoxicillin dose withheld, were given an oral amoxicillin dose of 25 mg/kg. Thereafter two blood samples and one MEF sample by tympanocentesis were collected from each child at selected times between 0.5 and 4.0 h after dosing for bacterial and viral studies and amoxicillin concentration determination by high performance liquid chromatography. RESULTS: Eleven (37%) children had only bacterial infection, 6 (20%) had viral infection only, 6 (20%) had both bacterial and viral infections and in 7 (23%) neither bacterial nor viral pathogens were recovered. MEF bacterial culture was positive in 23 of 40 ears (57.5%) before treatment with amoxicillin (40 mg/kg/day) and was still positive in 4 of 38 ears (10.5%) after 2 to 3 days of treatment. Amoxicillin plasma concentration reached its peak at 1.0 to 1.5 h after a 25-mg/kg oral dose. The estimated MEF concentration peak occurred 3.0 h after the dose with MEF concentrations ranging from undetectable to 20.6 microg/ml and a mean of approximately 9.5 microg/ml. Geometric mean amoxicillin concentrations were lowest in virus-infected children (2.7 microg/ml), nearly the same in culture-negative samples from children without viral infection (2.9 microg/ml), higher in children with combined bacterial and viral infection (4.1 microg/ml) and highest in children with bacterial-only infection (5.7 microg/ml). CONCLUSIONS: MEF amoxicillin penetration tended to be lower in children with viral infection. The current amoxicillin dosing recommendation of 40 mg/kg/day in three divided dose is inadequate to effectively eradicate resistant Streptococcus pneumoniae, particularly during viral coinfection. A dosing regimen of 75 to 90 mg/kg/day is recommended for AOM.

Acute otitis media: management and surveillance in an era of pneumococcal resistance--a report from the Drug-resistant Streptococcus pneumoniae Therapeutic Working Group.

OBJECTIVE: To provide recommendations [corrected] for the management of acute otitis media (AOM) and the surveillance of drug-resistant Streptococcus pneumoniae (DRSP). Five questions were addressed: (1) Can amoxicillin remain the best initial antimicrobial agent for treating AOM in the current period of increasing prevalence of DRSP? (2) What are suitable alternative agents for use if amoxicillin fails? (3) Should empiric treatment of AOM vary by geographic region? (4) Where can clinicians learn about resistance patterns in their patient populations? (5) What modifications to laboratory surveillance would improve the utility of the information for clinicians treating AOM? PARTICIPANTS: Experts in the management of otitis media and the DRSP Therapeutic Working Group. This group was convened by the CDC to respond to changes in antimicrobial susceptibility among pneumococci and includes clinicians, academicians and public health practitioners. EVIDENCE: Published and unpublished data summarized from the scientific literature and experience from the experts present. PROCESS: [corrected] After group presentations and review of background materials, subgroup chairs prepared draft responses to the five questions, discussed the responses as a group and edited those responses [corrected]. CONCLUSIONS: Oral amoxicillin should remain the first line antimicrobial agent for treating AOM. In view of the increasing prevalence of DRSP, the safety of amoxicillin at higher than standard dosages and evidence that higher dosages of amoxicillin can achieve effective middle ear fluid concentrations, an increase in the dosage used for empiric treatment from 40 to 45 mg/kg/day to 80 to 90 mg/kg/day is recommended. For patients with clinically defined treatment failure after 3 days of therapy, useful alternative agents include oral amoxicillin-clavulanate, cefuroxime axetil and intramuscular ceftriaxone. Many of the 13 other Food and Drug Administration-approved otitis media drugs lack good evidence for efficacy against DRSP. Currently local surveillance data for pneumococcal resistance that are relevant for the clinical management of AOM are not available from most areas in the United States. Recommendations to improve surveillance include establishing criteria for setting susceptibility breakpoints for clinically appropriate antimicrobials to ensure relevance for treating AOM, testing middle ear fluid or nasal swab isolates in addition to sterile site isolates and testing of drugs that are useful in treating AOM. The management of otitis media has entered a new era with the development of DRSP. These recommendations are intended to provide a framework for appropriate clinical and public health responses to this problem.

A controlled trial comparing three treatments for chronic otitis media with effusion.

A randomized, controlled clinical trial was conducted in 76 children to evaluate the efficacy of trimethoprim-sulfamethoxazole for 4 weeks, prednisone for 2 weeks and aluminum ibuprofen suspension for 2 weeks in resolving chronic otitis media with effusion which had persisted for more than 8 weeks. After 2 weeks of treatment resolution rates of chronic otitis media with effusion in the prednisone and trimethoprim-sulfamethoxazole groups were significantly greater than those in the control (no treatment) and ibuprofen groups. After 4 weeks the differences in resolution rates between the control, trimethoprim-sulfamethoxazole and prednisone groups became smaller. After 12 months of follow-up, differences in hearing sensitivity among study groups were not statistically significant, although 83% of patients had a 15-dB or greater hearing loss. Therefore short term antimicrobial and antiinflammatory treatment did not appear to have a long lasting effect on chronic middle ear inflammation.

Randomized trial of the efficacy of trimethoprim-sulfamethoxazole and prednisone in preventing post-tympanostomy tube morbidity.

This study was designed to determine whether treatment with prednisone and trimethoprim-sulfamethoxazole would reduce first year post-operative morbidity in children with chronic otitis media with effusion undergoing tympanostomy tube insertion (intubation). Eighty children ages 6 months to 8 years were enrolled at intubation and randomized from age strata to receive active drugs or placebos for 14 days after surgery. They were examined with pneumatic otoscopy and tympanometry preoperatively and at 3 weeks and 3, 6, 9 and 12 months after surgery. Active drug treatment significantly reduced tube obstruction or extrusion in the first 3 postoperative months compared with placebos (4% vs. 17%, P = .01). However, rates of repeat intubation, otorrhea and recurrence of otitis media did not differ significantly in the two groups. Children with chronic otitis media with effusion treated with intubation may benefit from a 2-week course of prednisone and trimethoprim-sulfamethoxazole at the time of surgery. However, there is no apparent long term benefit of this treatment.

Determining risk for chronic otitis media with effusion.

Chronic otitis media with effusion (OME) has been observed in 10 to 20% of children following acute, symptomatic otitis media. To determine factors that place children at increased risk of chronic OME, we conducted a 6-week prospective study of 386 children who had 3 or more recent episodes of otitis media and who had middle ear effusion present for at least 2 weeks. Of these children 23% developed chronic OME (i.e. effusion lasting 8 continuous weeks or more), and 26% developed chronic OME complicated by acute, symptomatic otitis media. Predictors for chronic OME were (1) bilateral OME, (2) duration of effusion for greater than 2 weeks at enrollment and (3) day care attendance. Children with these 3 factors had twice the risk of developing chronic OME as children lacking all 3 factors. These risk factors can be used to target children for early, aggressive OME therapy.

Vaccination against middle-ear bacterial and viral pathogens.

Considerable evidence suggests that otitis media (OM) can be prevented by systemic immunization. Building on the highly effective H. influenzae type b (Hib) conjugate vaccine technology, pneumococcal conjugate vaccines are being developed to circumvent T-independence of these antigens and provide durable immunity at a very young age. Several pneumococcal conjugate vaccines are currently in clinical testing. Potential vaccine antigens of nontypable H. influenzae (NTHi) include OMP, HMW, pili, and fimbriae. Several OMPs show extensive homology among strains, but surface, determinants of others are highly variable so that antibodies to surface epitopes of one strain will not bind to surface epitopes of another. Several M. catarrhalis OMP and HMW antigens have vaccine potential, but no functional correlates of protection have been identified, and there is no clear evidence that antibody to M. catarrhalis is associated with OM protection. Attenuated viral vaccines also hold promise of preventing childhood OM. Two clinical trials with killed influenza vaccines have shown a significant reduction in OM among vaccine recipients compared to control children during periods of high influenza disease activity in the community. Passive immunoprophylaxis also has potential for preventing OM. Human bacterial polysaccharide immune globulin was protective for pneumococcal OM in children and in the chinchilla OM model. High-dose respiratory syncytial virus-enriched immunoglobulin reduced the incidence and severity of RSV lower respiratory tract infection in high-risk children. Passive immunoprophylaxis may also be effective in children with specific immune deficiencies, such as IgG2 deficiency, and patients who fail to respond to vaccines.

Otitis media: the chinchilla model.

Streptococcus pneumoniae infection and disease have been modeled in several animal species including infant and adult mice, infant and adult rats, infant Rhesus monkeys, and adolescent and adult chinchillas. Most are models of sepsis arising from intravenous or intraperitoneal inoculation of bacteria, and a few were designed to study disease arising from intranasal infection. Chinchillas provide the only animal model of middle ear pneumococcal infection in which the disease can be produced by very small inocula injected into the middle ear (ME) or intranasally, and in which the disease remains localized to the ME in most cases. This model, developed at the University of Minnesota in 1975, has been used to study pneumococcal pathogenesis at a mucosal site, immunogenicity and efficacy of pneumococcal capsular polysaccharide (PS) vaccine antigens, and the kinetics and efficacy of antimicrobial drugs. Pathogenesis experiments in the chinchilla model have revealed variation in ME virulence among different pneumococcal serotypes, enhancement of ME infection during concurrent intranasal influenza A virus infections, and natural resolution of pneumococcal otitis media (OM) without intervention. Research has explored the relative contribution of pneumococcal and host products to ME inflammation. Pneumococcal cell wall components and pneumolysin have been studied in the model. Host inflammatory responses studied in the chinchilla ME include polymorphonuclear leukocyte oxidative products, hydrolytic enzymes, cytokine and eicosanoid metabolites, and ME epithelial cell adhesion and mucous glycoprotein production. Both clinical (tympanic membrane appearance) and histopathology (ME, Eustachian tube, inner ear) endpoints can be quantified. Immunologic and inflammatory studies have been facilitated by the production of affinity-purified antichinchilla immunoglobulin G (IgG), IgM, and secretory IgA polyclonal antibody reagents, and the identification of cross-reactivity between human and chinchilla cytokines, and between guinea pig and chinchilla C3. Alteration of ME mucosa by pneumococcal neuraminidase and alteration of ME epithelial cell (MEEC) surface carbohydrates during intranasal pneumococcal infection have been demonstrated. Pathogenesis studies have been aided by cultured chinchilla MEEC systems, in which the ability of platelet activating factor and interleukin (IL)-1 beta to stimulate epithelial mucous glycoprotein synthesis has recently been demonstrated. Because chronic OM with effusion is characterized by presence of large amounts of mucous glycoprotein in the ME, pneumococcus may have an important role in both acute and chronic ME disease. Both unconjugated PS and PS-protein-conjugated vaccines are immunogenic after intramuscular administration without adjuvant in chinchillas. Passive protection studies with human hyperimmune immunoglobulin demonstrated that anti-PS IgG alone is capable of protecting the chinchilla ME from direct ME challenge with pneumococci. Active PS immunization studies demonstrated protection following direct ME and intranasal pneumococcal challenge with and without concurrent influenza A virus infection. An attenuated influenza A virus vaccine also showed protection for pneumococcal OM. Antimicrobial treatment of acute OM has been based almost exclusively on empirical drug use and clinical trials without a foundation of ME pharmacokinetics. Studies in the chinchilla model have started to bring a rational basis to drug selection and dosing. Microassays have been developed using high-pressure liquid chromatography for many relevant drugs. Studies have explored the in vivo ME response in pneumococcal OM to antimicrobial drugs at supra- and sub-minimum inhibitory concentration (MIC), the effect of concurrent influenza A virus infection on ME drug penetration, and the effect of treatment on sensorineural hearing loss produced by pneumococcal OM.

Microdialysis studies of the middle ear distribution kinetics of amoxicillin in the awake chinchilla.

This work was performed to develop an experimental animal model for the study of antibiotic drug distribution into middle ear fluid (MEF) and to evaluate its relevance and significance to the clinical treatment of otitis media (OM). Chinchillas were assigned to normal or infected ear groups after Eustachian tube obstruction (ETO) or direct trans-bullar inoculation with type 3 Streptococcus pneumoniae. Following survival surgery to implant microdialysis (MD) probes in the jugular vein and middle ear (ME), amoxicillin was given intravenously (iv) as a bolus or infusion. Drug concentrations in blood and MEF were continuously monitored by microdialysis. The measured concentrations were corrected for probe recovery by simultaneous retrodialysis. Multiple MEF and blood sampling was also performed to validate the animal model and MD sampling technique. Bacterial infection was successfully induced 3-7 days after the inoculation, whereas the control group gave negative bacterial culture results. The beta-lactam antibiotic, amoxicillin, exhibited an elimination half-life of 0.33+/-0.23 h (n = 9) in chinchilla blood, 1.46+/-0.50 h (n = 5) and 1.75+/-0.84 h (n = 4) in MEF of normal and infected ears (p = 0.6), respectively. MEF-to-blood amoxicillin concentration ratios at steady state following iv infusion were 0.26+/-0.06 (n = 5) and 0.28+/-0.11 (n = 4) for normal and infected ears (p = 0.7), respectively. MD allows continuous monitoring of drug concentration-time profiles in blood and MEF in an awake chinchilla model. The concentrations measured by MD were validated by direct sampling. The ratio of the area under the curve (AUC) of drug concentration in MEF versus time to that in blood after iv bolus doses was less than unity, as was the steady-state concentration ratio following constant-rate iv infusion, suggesting an active transport mechanism was involved in the efflux of amoxicillin from the ME of chinchilla. The results of studies involving infected ears were not significantly different from those in normal ears in terms of amoxicillin distribution across the ME mucosal membrane after systemic administration.

Panel discussion: pathogenesis of otitis media. Pathology and microbiology of otitis media.

Otitis media (OM) can be subdivided into purulent, serous, mucoid, and chronic forms. It may occur in the absence of tympanic membrane changes and involve the inner ear. Purulent otitis media is characterized early by edema, hyperemia, and polymorphonuclear leukocyte infiltration in the subepithelial space (SES) and later by mucosal metaplasia, granulation tissue, and osteitis. S. pneumoniae and H. influenza are most commonly identified. Serous and mucoid OM frequently develop from eustachian tube dysfunction. Serous transudate from vessels in the SES passes to the middle ear (serous otitis media). Basal cells differentiate into goblet cells and subepithelial glandular formation occurs. This secretory activity, coupled with fluid reabsorption, results in a mucoid effusion. Bacteria can be cultured from about 30% of these effusions. Chronic otitis media denotes irreversible tissue pathology. It may be sterile although S. aureus and coliform bacteria are frequently isolated.

Prediction of serous versus purulent otitis media by otoscopy and tympanometry in an animal model.

Non-invasive methods for distinguishing different types of otitis media would have clinical value in predicting otologic morbidity. Two such methods, otoscopy and tympanometry, were used in two experimental models of otitis media to determine whether there are unique otoscopic and tympanometric characteristics of serous and purulent otitis media. A flat (type B or B+) tympanogram and yellow tympanic membrane each had a high likelihood of predicting middle ear effusion in these models, and the best prediction was obtained using both parameters simultaneously. A yellow tympanic membrane color predicted purulent otitis media in one model but did not distinguish purulent from serous ears in the other model. In one model, serous otitis media was frequently associated with a type C (negative pressure) tympanogram. Tympanometry provided a valuable adjunct to otoscopy in detecting effusion and in distinguishing serous and purulent disease. These observations may apply to otitis media in humans, although the variable etiologies of otitis media in humans may confound the ability of otoscopy and tympanometry to distinguish middle ear effusion types.

Relationships between otitis media sequelae and age.

OBJECTIVES: To explore relationships between age and sequelae in two groups of children treated with tympanostomy tubes for chronic otitis media with effusion (OME). STUDY DESIGN: Cross-sectional study of sequelae among children, adolescents, and adults at 4 years and 9 to 23 years after tympanostomy tube treatment. METHODS: Group I was examined with otomicroscopy, tympanometry, and audiometry two to four times a year as part of a prospective study, and they were evaluated 4 years after initial tube treatment for this study. Group II received tubes while participating in a chronic OME study, but participants were not followed prospectively after treatment. Nine to 23 years after tube treatment, they were examined with otomicroscopy, tympanometry, and hearing screening. RESULTS: Among the 5- to 28- year-old subjects, cholesteatoma (< or = 1%) and perforation (< or = 2%) were rare. In Group I, tympanosclerosis increased with age (P < .01), and OME (flat tympanograms) decreased with age in Group II (P < .01). The older cohort was more likely to have severe retractions (18% vs. 4%, P = .02), hearing loss (21% vs. 10%, P < .01), and severe atrophy (24% vs. 0%, P < .01) than the younger cohort, but they were less likely to have flat tympanograms (2% vs. 12%, P < .01). CONCLUSIONS: Although OME became less prevalent with age, important sequelae (severe atrophy, severe tympanic membrane retraction, hearing loss, cholesteatoma, and chronic perforation) may develop in children with chronic OME as they become adolescents and young adults. Long-term prospective studies are important in defining the progression of sequelae in these children.

Treatment evaluation in otitis media research.

OBJECTIVE: An application of the clinical otitis media profile is proposed for the evaluation of treatments in clinical studies of otitis media. METHODS: Methods include a statistical test of significance and measures of "treatment difference." This article focuses on the method, not any particular study; however, an example is given to illustrate the ideas. CONCLUSIONS: The proposed method substantially increases powers of statistical tests, as compared with the use of a two-point scale algorithm, when applied to study changes of the middle ear condition over time or to compare treatment effects. The proposed evaluation method is applicable to any medical drug treatment for groups that may not be comparable, even with randomization, for baseline severity. Applied to surgical treatment, it can be used for long-term evaluation; however, short-term evaluation is impossible because the needed tympanometric, static admittance, and width measurements cannot be obtained in the presence of functioning tubes. To achieve this objective, it is necessary to use another profile or diagnostic procedure.

A clinical profile of otitis media.

An otitis media with effusion algorithm developed by Paradise et al and tested by Cantekin et al has become the basis for many studies of otitis media. However, a two-point scale algorithm (otitis media with effusion-no otitis media with effusion) may be too ambitious (ie, low specificity) and too optimistic (ie, absence of fluid does not necessarily mean normal ear). We propose a four-point profile that characterizes the condition of the middle ear, and we report the validation of the profile against findings at myringotomy. Statistically, a four-point scale profile would substantially increase powers of statistical tests, compared with a two-point scale algorithm (in studies of the same size), when used to study changes of the middle-ear condition over time or to compare treatment effects.

Low cord blood pneumococcal antibody concentrations predict more episodes of otitis media.

OBJECTIVE: To determine if cord blood anticapsular polysaccharide pneumococcal IgG antibody concentration was related to the number of otitis media (OM) and acute OM episodes during the first year of life. DESIGN: Prospective study following infants from birth to 24 months. SETTING: Health maintenance organization. PATIENTS: The study population consisted of 415 infants whose mothers volunteered for the study during pregnancy. Cord blood samples were collected and infants were followed up for OM in the health maintenance organization. Ninety-seven percent of the infants were white, 49% male, 3% from households with annual incomes of less than $20 000, and 30% from households with annual incomes of more than $60 000. MAIN OUTCOME MEASURE: Number of physician-diagnosed OM episodes, including both OM with effusion and acute OM, and acute OM episodes from birth to 12 months. RESULTS: With univariate analysis, low cord blood antibody concentrations against serotypes 3 and 19F predicted more acute OM episodes (P =.04 and P =.05, respectively), and low antibody concentrations against serotypes 19F and 23F predicted more OM episodes (P =.04 and P =.05, respectively) over the first year of life. With Poisson regression, which adjusted for variables related to the recurrence of OM and having low cord blood antibody concentrations, serotype 19F remained significantly related to the number of OM episodes (relative risk for lowest quartiles vs upper 3 quartiles 1.23; 95% confidence interval, 1.02-1.50; P =.03). CONCLUSIONS: Low cord blood antibody concentrations to serotype 19F predicted more OM episodes over the first 12 months of life. These results suggest the potential benefit of maternal immunization to raise neonatal antipolysaccharide pneumococcal antibody concentration and delay the onset and reduce the number of OM episodes.

Predictors for postoperative otorrhea following tympanostomy tube insertion.

This controlled prospective study was designed to identify predictors for postoperative otorrhea among 157 children with chronic otitis media with effusion undergoing myringotomy and tympanostomy tube placement (intubation). Ear canal disinfection with 70% alcohol or povidone-iodine did not significantly alter ear canal or middle ear effusion bacteriology, or the frequency of otorrhea during the first 7 days after surgery. However, the risk of otorrhea on the second postoperative day was significantly increased by the presence of a bacterial pathogen in the ear canal (relative risk, 2.4), or in the middle ear effusion (relative risk, 1.9), and the presence of inflamed middle ear mucosa at surgery (relative risk, 1.7) after controlling for age, preoperative antibiotics, and postoperative ototopical cortisporin treatment. The use of systemic antimicrobial treatment in children with inflamed middle ear mucosa at surgery or whose ear canal or middle ear effusion cultures are positive for bacterial pathogens might reduce the incidence of post-operative otorrhea in children undergoing intubation for chronic otitis media with effusion.

A clinical profile of otitis media without an intact tympanic membrane.

An otitis media with effusion algorithm developed by Paradise et al has become the basis for many studies of otitis media. However, it has been shown to be too ambitious (low specificity) and too optimistic (absence of fluid does not necessarily mean normal ears). We developed a four-point profile to characterize the condition of the middle ear, but it cannot be used when the eardrum is perforated (with a functioning tube or chronic perforation). We propose a three-point profile for use without an intact tympanic membrane, and we report the validation of the profile by findings at myringotomy and by the preoperative profile. This postoperative profile and the previously described profile for ears with an intact tympanic membrane should increase the accuracy of middle ear assessment in following the course of otitis media over time.