Otorrhea in young children after tympanostomy-tube placement for persistent middle-ear effusion: prevalence, incidence, and duration.

OBJECTIVE: To characterize the occurrence of tube otorrhea after tympanostomy-tube placement (TTP) for persistent middle-ear effusion (MEE) in a group of otherwise healthy infants and young children. METHODS: In a long-term, prospective study of child development in relation to early-life otitis media, we enrolled by 2 months of age healthy infants who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small-town/rural and 4 suburban private pediatric group practices. We monitored their middle-ear status closely. Children who developed persistent MEE of specified durations within the first 3 years of life became eligible for random assignment to undergo TTP either promptly or after an extended period if MEE persisted. The present report concerns 173 randomly assigned children who underwent bilateral TTP between ages 6 and 36 months and were followed for at least 6 months thereafter. Episodes of tube otorrhea were treated with oral antimicrobial drugs and, if persistent, with ototopical medication. RESULTS: Socioeconomic status, as estimated from maternal education and type of health insurance, was lowest at the urban sites and highest at the suburban sites. The tenure of the 230 tubes that were extruded during the observation period ranged from 19 days to 38.5 months (mean = 13.8 months; median = 13.5 months). During the first 18 months after TTP, the proportion of children who had tubes in place and who developed 1 or more episodes of otorrhea increased progressively, reaching 74.8% after 12 months and 83.0% after 18 months. The mean number of episodes per child was 0.79 in the first 6 months, 1.50 in the first 12 months, 2.17 in the first 18 months, and 2.82 in the first 24 months. Overall, otorrhea occurred earliest and was most prevalent among urban children and occurred latest and was least prevalent among suburban children. The mean estimated duration of episodes of tube otorrhea was 16.0 days (standard deviation = 16.9 days), the median was 10 days, and the range was 3 to 131 days. The duration was >30 days in 13.2% of the episodes. Six of the 173 children (3.5%) developed on 1 or more occasions tube otorrhea that failed to improve satisfactorily with conventional outpatient management. Five of these children were hospitalized to receive parenteral antibiotic treatment, 1 child twice and 1 three times, and 1 also underwent tube removal. The sixth child underwent tube removal as an outpatient. CONCLUSIONS: Tube otorrhea is a common and often recurrent and/or stubborn problem in young children who have undergone tube placement for persistent MEE. The extent of the problem seems to be related inversely to socioeconomic status. Tube otorrhea does not always respond satisfactorily to outpatient management and for resolution may require parenteral antimicrobial treatment and/or tube removal.

Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years.

BACKGROUND: A main indication for the insertion of tympanostomy tubes in infants and young children is persistent otitis media with effusion, reflecting concern that this condition may cause lasting impairments of speech, language, cognitive, and psychosocial development. However, evidence of such relations is inconclusive, and evidence is lacking that the insertion of tympanostomy tubes prevents developmental impairment. METHODS: We enrolled 6350 healthy infants from 2 to 61 days of age and evaluated them regularly for middle-ear effusion. Before the age of three years 429 children with persistent effusion were randomly assigned to have tympanostomy tubes inserted either as soon as possible or up to nine months later if effusion persisted. In 402 of these children we assessed speech, language, cognition, and psychosocial development at the age of three years. RESULTS: By the age of three years, 169 children in the early-treatment group (82 percent) and 66 children in the late-treatment group (34 percent) had received tympanostomy tubes. There were no significant differences between the early-treatment group and the late-treatment group at the age of three years in the mean (+/-SD) scores on the Number of Different Words test, a measure of word diversity (124+/-32 and 126+/-30, respectively); the Percentage of Consonants Correct-Revised test, a measure of speech-sound production (85+/-7 vs. 86+/-7); the General Cognitive Index of McCarthy Scales of Children's Abilities (99+/-14 vs. 101+/-13); or on measures of receptive language, sentence length, grammatical complexity, parent-child stress, and behavior. CONCLUSIONS: In children younger than three years of age who have persistent otitis media, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at the age of three years.

Measurement properties of the MacArthur communicative development inventories at ages one and two years.

In a prospective study of child development in relation to early-life otitis media, we administered the MacArthur Communicative Development Inventories (CDI) to a large (N = 2,156), sociodemographically diverse sample of 1- and 2-year-old children. As a prerequisite for interpreting the CDI scores, we studied selected measurement properties of the inventories. Scores on the CDI/Words and Gestures (CDI-WG), designed for children 8 to 16 months old, and on the CDI/Words and Sentences (CDI-WS), designed for children 16 to 30 months old, increased significantly with months of age. On several scales of both CDI-WG and CDI-WS, standard deviations approximated or exceeded mean values, reflecting wide variability in results. Statistically significant differences in mean scores were found according to race, maternal education, and health insurance status as an indirect measure of income, but the directionality of differences was not consistent across inventories or across scales of the CDI-WS. Correlations between CDI-WG and CDI-WS ranged from .18 to .39. Our findings suggest that the CDI reflects the progress of language development within the age range 10 to 27 months. However, researchers and clinicians should exercise caution in using results of the CDI to identify individual children at risk for language deficits, to compare groups of children with different sociodemographic profiles, or to evaluate the effects of interventions.

Language, speech sound production, and cognition in three-year-old children in relation to otitis media in their first three years of life.

OBJECTIVE: As part of a prospective study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we tested relationships between children's cumulative duration of middle ear effusion (MEE) in their first 3 years of life and their scores on measures of language, speech sound production, and cognition at 3 years of age. METHODS: We enrolled 6350 healthy infants by 2 months of age who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small town/rural and 4 suburban private pediatric practices. We intensively monitored the children's middle ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 3 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. Children who met specified minimum criteria regarding the persistence of MEE became eligible for a clinical trial in which they were assigned randomly to undergo tympanostomy tube placement either promptly or after a defined extended period if MEE remained present. From among those remaining, we selected randomly, within sociodemographic strata, a sample of 241 children who represented a spectrum of MEE experience from having no MEE to having MEE whose cumulative duration fell just short of meeting randomization criteria. In subjects so selected, the estimated duration of MEE ranged from none to 65.6% of the first year of life and 44.8% of the first 3 years of life. In these 241 children we assessed language development, speech sound production, and cognition at 3 years of age, using both formal tests and conversational samples. RESULTS: We found weak to moderate, statistically significant negative correlations between children's cumulative durations of MEE in their first year of life or in age periods that included their first year of life, and their scores on formal tests of receptive vocabulary and verbal aspects of cognition at 3 years of age. However, the percent of variance in these scores explained by time with MEE in the first year of life beyond that explained by sociodemographic variables ranged only from 1.2% to 2.9%, and the negative correlations were concentrated in the subgroup of children whose families had private health insurance (rather than Medicaid). We found no significant correlations in the study population as a whole or in any subgroup between time with MEE during antecedent periods and children's scores on measures of spontaneous expressive language, speech sound production, or other measured aspects of cognition. In contrast, by wide margins, scores on all measures were consistently highest among the most socioeconomically advantaged children and lowest among the most socioeconomically disadvantaged children. CONCLUSIONS: Our findings suggest either that persistent early-life MEE actually causes later small, circumscribed impairments of receptive language and verbal aspects of cognition in certain groups of children or that unidentified, confounding factors predispose children both to early-life otitis media and to certain types of developmental impairment. Findings in the randomized clinical trial component of the larger study should help distinguish between causality and confounding as explanations for our findings.language, speech, cognition, development, otitis media, middle ear effusion.

Maternal education and measures of early speech and language.

The present study was designed to determine whether 4 measures of children's spontaneous speech and language differed according to the educational level of the children's mothers. Spontaneous language samples from 240 three-year-old children were analyzed to determine mean length of utterance in morphemes (MLUm), number of different words (NDW), total number of words (TNW), and percentage of consonants correct (PCC). A norm-referenced, knowledge-dependent measure of language comprehension, the Peabody Picture Vocabulary Test-Revised (PPVT-R), was also included for purposes of comparison with the spontaneous measures. Three levels of maternal education were compared: less than high school graduate, high school graduate, and college graduate. Trend analyses showed statistically significant linear trends across educational levels for MLUm, NDW, TNW, and PPVT-R; the trend for PCC was not significant. The relationship of maternal education and other sociodemographic variables to measures of children's language should be examined before using such measures to identify children with language disorders.

Parental stress and parent-rated child behavior in relation to otitis media in the first three years of life.

OBJECTIVE: As part of a long-term study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we tested relationships between parents' ratings of parent-child stress at ages 1, 2, and 3 years, and of their children's behavior problems at ages 2 and 3 years, and the children's cumulative duration of middle-ear effusion (MEE) in their first 3 years of life. METHODS: We enrolled healthy infants by age 2 months who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small-town/rural and 4 suburban private pediatric practices. We obtained standardized baseline measures of parental stress; we intensively monitored the children's middle-ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 3 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. We obtained parent ratings of parental stress using the Parenting Stress Index/Short Form when the children reached ages 1, 2, and 3 years, and parent ratings of children's behavior using the Child Behavior Checklist when the children reached ages 2 and 3 years. RESULTS: In 2278 children we found no substantial relationships between parents' ratings of parent-child stress when the children reached ages 1, 2, and 3 years, or of their children's behavior problems at ages 2 and 3 years, and the cumulative duration of the children's MEE during antecedent periods. On the other hand, ratings both of parent-child stress and of behavior problems were consistently highest among the most socioeconomically disadvantaged children and lowest among the most socioeconomically advantaged children. Ratings also tended to be highest among children whose parents' baseline stress scores were highest. CONCLUSIONS: Parent-child stress and children's behavior problems in the first 3 years of life, as rated by parents, bear little or no relationship to the children's previous cumulative duration of MEE.

Parent-reported language and communication skills at one and two years of age in relation to otitis media in the first two years of life.

OBJECTIVE: As part of a study of possible effects of early life otitis media on children's development, we attempted to determine whether levels of language and communication skills at 1 and 2 years of age are associated with the cumulative duration of middle ear effusion (MEE) in the first 2 years of life. METHODS: Subjects (N = 2156) were followed at one of eight study sites in the Pittsburgh area. Middle ear status was monitored closely throughout the first 2 years of life. For each child, the cumulative percentage of days with MEE was estimated based on diagnoses at visits and interpolations for intervals between visits. For each child also, 1 or both parents completed the MacArthur Communicative Development Inventory-Words and Gestures (CDI-WG) when the child was 1 year of age and the MacArthur Communicative Development Inventory-Words and Sentences (CDI-WS) when the child was 2 years of age. RESULTS: Unadjusted correlations between scores on the CDI-WG and percentage of days with MEE in the first year of life were close to zero, and there were no statistically significant negative correlations. Unadjusted correlations between scores on the CDI-WS and the cumulative percentage of days with MEE in year 2 and in years 1 and 2 combined were generally negative and statistically significant, but the magnitudes of those correlations were no higher than 0.09. After adjustment for sociodemographic variables, only the Vocabulary Production Scale of the CDI-WS remained correlated significantly with the percentage of days with MEE, and the percentage of days with MEE accounted for only a negligible percentage of the variance in scores on this scale. CONCLUSIONS: In this diverse sample of children, parent-reported levels of language skills at 1 and 2 years of age were correlated negligibly with the cumulative percentage of days with MEE in the children's first and second years of life. otitis media, otitis media with effusion, language, communication.

Adenoidectomy and adenotonsillectomy for recurrent acute otitis media: parallel randomized clinical trials in children not previously treated with tympanostomy tubes.

CONTEXT: Adenoidectomy and adenotonsillectomy are commonly performed in US children to reduce the occurrence of persistent or recurrent otitis media, but evidence supporting the efficacy of the operations is limited. OBJECTIVES: To test the efficacy of adenoidectomy and adenotonsillectomy in children with persistent or recurrent otitis media who had not previously undergone tube placement and to compare the relative efficacy of adenoidectomy alone vs adenotonsillectomy in such children. DESIGN: Two parallel randomized clinical trials. SETTING AND PARTICIPANTS: A total of 461 children aged 3 to 15 years were enrolled at Children's Hospital of Pittsburgh, Pa, between April 1980 and April 1994. Four hundred ten children were observed for up to 3 years. INTERVENTIONS: Children without recurrent throat infection or tonsillar hypertrophy (304 enrolled; 266 followed up) were randomized to either an adenoidectomy, adenotonsillectomy, or control group; children who had such conditions (157 enrolled; 144 followed up) were randomized to an adenotonsillectomy or control group. MAIN OUTCOME MEASURES: Occurrence rate of episodes of acute otitis media by treatment group and estimated proportion of time with otitis media. RESULTS: In both trials, most subjects were eligible because of recurrent acute otitis media, with or without persistent otitis media with effusion. A total of 47 children assigned to surgical treatment groups had no surgery. The efficacy of surgery in both trials was modest and limited mainly to the first follow-up year. The largest differences in that year were found in the 3-way trial between the adenotonsillectomy group and the control group: mean annual rate of episodes of acute otitis media, 1.4 vs 2.1 (P<.001); and mean estimated percentage of time with otitis media, 18.6% vs 29.9% (difference, 11.3%; 95% confidence interval, 4.4%-18.2%; P=.002). Perioperative and postoperative complications or other adverse events occurred not infrequently, especially among subjects undergoing adenotonsillectomy (14.6%). CONCLUSIONS: Our study showed limited and short-term efficacy of both adenoidectomy and adenotonsillectomy; given the risks, morbidity, and costs of these procedures, these data suggest that neither operation should ordinarily be considered as a first surgical intervention in children whose only indication is recurrent acute otitis media.

Otitis media and child development: should we worry?

Persistent middle ear effusion in infancy and early childhood has been blamed for impairments of speech, language, cognition and psychosocial development later in life. Whether that blame is justified remains unresolved and a matter of controversy, because studies of the relationships involved have been limited and often contradictory and because none was designed so as to address the issue of causality. At issue in particular is the common practice of subjecting infants and young children with persistent otitis media with effusion (OME) to tympanostomy tube placement specifically to reduce the risk of developmental impairment. Currently children younger than age 3 years undergo an estimated 313000 tympanostomy tube placement operations per year, at a cost of about $750 million. If a causal association between early life OME and later developmental impairment were to be established, answers would also be needed to the questions whether the adverse effects of OME are linear or threshold, whether they are permanent or transient and whether they are preventable by timely tube placement. A prospective study designed to address all of these questions is currently under way at Children's Hospital of Pittsburgh. The study involves enrolling a large, demographically diverse sample of normal infants before 2 months of age; monitoring them for the presence or absence of otitis media throughout the first 3 years of life; identifying those in whom OME has persisted for specified minimum periods; randomly assigning those subjects either to prompt tube placement or to delayed tube placement if OME persists; and administering a battery of standardized developmental tests to those subjects and to a sample of the others at ages 3, 4 and 6 years. Details of the study design and procedures are described in this report.

Assessment of adenoidal obstruction in children: clinical signs versus roentgenographic findings.

OBJECTIVE: As part of a comprehensive study of indications for tonsillectomy and adenoidectomy, we investigated the reliability of standardized clinical assessments and standardized roentgenographic assessments of adenoidal obstruction of the nasopharynx, and the degree of correlation between clinical assessments and roentgenographic assessments. METHODS: We rated the degree of patients' mouth breathing and patients' speech hyponasality on a 4-point scale (none = 1; mild = 2; moderate = 3; marked = 4), we averaged the ratings for each child to obtain a Nasal Obstruction Index, and we determined levels of interobserver agreement concerning the ratings. We classified lateral soft-tissue roentgenograms of the nasopharynx, based on assessments of adenoid size and of nasopharyngeal airway patency, as showing either no obstruction, borderline obstruction, or obstruction, and we determined levels of inter- and intraobserver agreement concerning the classifications. Finally, we determined correlations in individual patients between clinical ratings and roentgenographic ratings of nasal/nasopharyngeal obstruction, and calculated the predictive values of clinical ratings based on roentgenographic ratings as the gold standard. RESULTS: In sets of paired examinations, weighted kappa values for interobserver agreement concerning mouth breathing (total, 235 children) and speech hyponasality (total, 648 children) ranged from 0.84 to 0.91. The value for interobserver agreement concerning roentgenographic assessment of nasopharyngeal airway status (207 children) was 0.92, and for intraobserver agreement (191 children) 0.88. The Kendall's tau b value for concordance between Nasal Obstruction Index values and roentgenographic ratings (1033 children) was 0.51. Nasal Obstruction Index values at the lower and upper extremes--i.e., 1.0 and > or = 3.5, respectively--were highly predictive of concordant roentgenographic ratings. CONCLUSIONS: We conclude that standardized clinical ratings of the degree of children's mouth breathing and speech hyponasality provide reliable and reasonably valid assessments of the presence and degree of adenoidal obstruction of the nasopharyngeal airway. These clinical assessments are particularly valid at the extremes of either marked obstruction or no obstruction. Clinical assessment alone may be insufficient to establish the presence of adenoidal obstruction, but clinical assessment alone when findings are unequivocally negative can suffice to rule out adenoidal obstruction with a high degree of confidence.

Acute otitis media in children with bronchiolitis.

OBJECTIVE: We investigated the prevalence and the etiology of acute otitis media (AOM) in children with bronchiolitis to determine whether AOM in such children is due entirely or mainly to respiratory syncytial virus (RSV), in which case routine antimicrobial treatment would not be appropriate. METHODS: The study group consisted of children aged 2 to 24 months with bronchiolitis. In patients with AOM at entry, nasal washings for RSV enzyme-linked immunosorbent assay were obtained, and Gram-stained smear, bacterial culture, and reverse transcriptase polymerase chain reaction to detect the presence of RSV were performed on middle-ear aspirates. Patients without AOM were reevaluated at 48 to 72 hours, 8 to 10 days, and 18 to 22 days. RESULTS: Forty-two children with bronchiolitis were enrolled. Sixty-two percent had AOM at entry or developed AOM within 10 days. An additional 24% had or eventually developed otitis media with effusion. Only 14% remained free of both AOM and otitis media with effusion throughout the 3-week observation period. All patients with AOM had 1 or more bacterial pathogens isolated from one or both middle-ear aspirates. Of 33 middle-ear aspirates, Streptococcus pneumoniae was isolated in 15, Haemophilus influenzae in 8, Moraxella catarrhalis in 8, and Staphylococcus aureus in 2. Two middle-ear aspirates yielded 2 pathogens each; 2 aspirates had no growth. RSV was identified in 17 (71%) of 24 patients with AOM. CONCLUSION: Bacterial AOM is a complication in most children with bronchiolitis. Accordingly, in patients with bronchiolitis and associated AOM, antimicrobial treatment is indicated.

Efficacy of Auralgan for treating ear pain in children with acute otitis media.

OBJECTIVE: To determine the efficacy of Auralgan otic solution (combination product of antipyrine, benzocaine, and glycerin) compared with an olive oil placebo in the management of moderate to severe ear pain in children with acute otitis media (AOM). DESIGN: Children 5 years or older who presented with ear pain and eardrum findings indicative of AOM were randomly assigned to treatment with Auralgan or olive oil drops instilled into the external auditory canal(s) of the affected ear(s). All children were also treated with 15 mg/kg of acetaminophen in a single dose. Ear pain was assessed by means of 2 visual analog seales-a linear scale and a color scale-at study entry and 10, 20, and 30 minutes later (T0, T10, T20, and T30, respectively). Results of the measurements on the 2 scales were evaluated independently and were averaged to determine an ear pain score. A baseline ear pain score of at least 3 points was required for study entry. Four outcome measures regarding ear pain score at T10, T20, and T30 were used: (1) proportion of subjects who showed 50% reduction, (2) proportion of subjects who showed 25% reduction, (3) proportion of subjects who showed a 1 or more point reduction, and (4) mean score over time. SETTING: Primary care center and emergency department of a children's hospital. PARTICIPANTS: Fifty-four children aged 5 to 19 years with ear pain and AOM. RESULTS: The Auralgan and placebo groups were comparable regarding age, sex, race, laterality of AOM, and T0 ear pain score. By each of the 4 measures used, the response to treatment consistently favored the Auralgan group, but only at T30 were any differences statistically significant. CONCLUSION: In children with AOM-associated ear pain who are treated with acetaminophen, topically applied Auralgan appears likely to provide additional relief in varying degree within 30 minutes.