Tympanostomy tubes and developmental outcomes at 9 to 11 years of age.

BACKGROUND: Developmental impairments in children have been attributed to persistent middle-ear effusion in their early years of life. Previously, we reported that among children younger than 3 years of age with persistent middle-ear effusion, prompt as compared with delayed insertion of tympanostomy tubes did not result in improved cognitive, language, speech, or psychosocial development at 3, 4, or 6 years of age. However, other important components of development could not be assessed until the children were older. METHODS: We enrolled 6350 infants soon after birth and evaluated them regularly for middle-ear effusion. Before 3 years of age, 429 children with persistent effusion were randomly assigned to undergo the insertion of tympanostomy tubes either promptly or up to 9 months later if effusion persisted. We assessed literacy, attention, social skills, and academic achievement in 391 of these children at 9 to 11 years of age. RESULTS: Mean (+/-SD) scores on 48 developmental measures in the group of children who were assigned to undergo early insertion of tympanostomy tubes did not differ significantly from the scores in the group that was assigned to undergo delayed insertion. These measures included the Passage Comprehension subtest of the Woodcock Reading Mastery Tests (mean score, 98+/-12 in the early-treatment group and 99+/-12 in the delayed-treatment group); the Spelling, Writing Samples, and Calculation subtests of the Woodcock-Johnson III Tests of Achievement (96+/-13 and 97+/-16; 104+/-14 and 105+/-15; and 99+/-13 and 99+/-13, respectively); and inattention ratings on visual and auditory continuous performance tests. CONCLUSIONS: In otherwise healthy young children who have persistent middle-ear effusion, as defined in our study, prompt insertion of tympanostomy tubes does not improve developmental outcomes up to 9 to 11 years of age. (ClinicalTrials.gov number, NCT00365092 [ClinicalTrials.gov].).

Tympanometric findings and the probability of middle-ear effusion in 3686 infants and young children.

OBJECTIVE: We examined relationships between tympanometric findings and the presence or absence of middle-ear effusion in a population-based sample of children under the age of 3 years. METHODS: In a study of children's development in relation to early-life otitis media, we enrolled 6350 infants soon after birth and evaluated them regularly for the presence of middle-ear effusion. In 3686 of the children, we compared tympanometric findings with otoscopic diagnoses. We categorized tympanograms according to varying combinations of tympanometric peak height, peak pressure, and width, and calculated for each resulting category the percentage of the associated ears diagnosed as having effusion. Using these findings we developed algorithms for estimating the probability of middle-ear effusion associated with tympanograms of any configuration. RESULTS: For tympanograms generally, the lower their height and the greater their width, the greater was the probability of associated middle-ear effusion; the probability also was greater when peak pressure was negative rather than positive. Among children > or = 6 months of age, effusion was diagnosed in only 2.7% of ears with tympanometric height > or = 0.6 mL, but in 80.2% of ears with flat tympanograms. Relationships among younger infants were similar but less consistent. In both age groups, the tympanographic configurations most commonly encountered were associated with either a relatively low probability (<30%) or a relatively high probability (>70%) of the presence of middle-ear effusion. The receiver operating characteristic curve we generated using the algorithm we developed for children > or = 6 months of age gave an area under the curve of 0.84. The algorithm performed equally well when applied to a separate group of children, suggesting that it is generalizable to other unselected populations. CONCLUSIONS: The present report offers two alternative methods for estimating the probability of middle-ear effusion in children aged 6 through 35 months, given any combination of tympanometric values.

Developmental outcomes after early or delayed insertion of tympanostomy tubes.

BACKGROUND: To prevent later developmental impairments, myringotomy with the insertion of tympanostomy tubes has often been undertaken in young children who have persistent otitis media with effusion. We previously reported that prompt as compared with delayed insertion of tympanostomy tubes in children with persistent effusion who were younger than three years of age did not result in improved developmental outcomes at three or four years of age. However, the effect on the outcomes of school-age children is unknown. METHODS: We enrolled 6350 healthy infants younger than 62 days of age and evaluated them regularly for middle-ear effusion. Before three years of age, 429 children with persistent middle-ear effusion were randomly assigned to have tympanostomy tubes inserted either promptly or up to nine months later if effusion persisted. We assessed developmental outcomes in 395 of these children at six years of age. RESULTS: At six years of age, 85 percent of children in the early-treatment group and 41 percent in the delayed-treatment group had received tympanostomy tubes. There were no significant differences in mean (+/-SD) scores favoring early versus delayed treatment on any of 30 measures, including the Wechsler Full-Scale Intelligence Quotient (98+/-13 vs. 98+/-14); Number of Different Words test, a measure of word diversity (183+/-36 vs. 175+/-36); Percentage of Consonants Correct-Revised test, a measure of speech-sound production (96+/-2 vs. 96+/-3); the SCAN test, a measure of central auditory processing (95+/-15 vs. 96+/-14); and several measures of behavior and emotion. CONCLUSIONS: In otherwise healthy children younger than three years of age who have persistent middle-ear effusion within the duration of effusion that we studied, prompt insertion of tympanostomy tubes does not improve developmental outcomes at six years of age.

Otitis media and tympanostomy tube insertion during the first three years of life: developmental outcomes at the age of four years.

OBJECTIVE: In a long-term, prospective study, we set out to determine whether otitis media in the first 3 years of life persisting for periods currently considered developmentally threatening actually results in later impairments of children's cognitive, language, speech, or psychosocial development; whether prompt insertion of tympanostomy tubes prevents or lessens any such impairments; and whether, irrespective of causality, associations exist between persistent early-life otitis media and later developmental impairments. This report describes findings in study participants at the age of 4 years. METHODS: We enrolled 6350 healthy infants from 2 to 61 days of age at urban hospitals and 2 small-town/rural and 4 suburban private pediatric practices. We regularly evaluated the children for the presence of middle-ear effusion (MEE) throughout their first 3 years of life by pneumatic otoscopy, supplemented by tympanometry; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. In the clinical trial component of the study, we randomly assigned 429 children who met specified minimum criteria regarding the persistence of MEE to undergo tympanostomy tube insertion either promptly or after a defined extended period if MEE remained present. In the associational component of the study, we selected a representative sample of 241 children who ranged from having no MEE to having MEE the cumulative duration of which fell just short of meeting randomization criteria for the clinical trial. In 397 (92.5%) of the children in the clinical trial and in 234 (97.1%) of the children in the representative sample, we assessed cognitive, language, speech, and psychosocial development at the age of 4 years, using formal tests, conversational samples, and parent questionnaires. RESULTS: In children in the randomized clinical trial, there were no statistically significant differences in mean (+/-standard deviation) scores (higher denotes more favorable) favoring the early-treatment group over the late-treatment group on the General Cognitive Index of the McCarthy Scales of Children's Abilities (97 +/- 14 and 98 +/- 14, respectively); the Peabody Picture Vocabulary Test-Revised, a measure of receptive language (90 +/- 15 vs 92 +/- 16); the Nonword Repetition Test, a measure of phonological memory (66 +/- 12 vs 70 +/- 12); the Number of Different Words, a measure of word diversity (150 +/- 34 vs 150 +/- 31); the Mean Length of Utterance in Morphemes, a measure of sentence length and grammatical complexity (3.4 +/- 0.8 vs 3.4 +/- 0.7); or the Percentage of Consonants Correct-Revised, a measure of speech-sound production (92 +/- 5 vs 93 +/- 5). There were also no significant differences in ratings (higher denotes less favorable) on the Parenting Stress Index-Short Form (Total Stress scores: 68 +/- 18 vs 65 +/- 17) or the Child Behavior Checklist (Total Problem T scores: 50 +/- 10 vs 49 +/- 10). In the associational component of the study, correlations between the children's durations of MEE and their developmental outcomes were generally weak and, in most instances, nonsignificant. Exceptions, after adjustment for sociodemographic variables and for hearing thresholds at the time of developmental testing, consisted of a significant negative correlation between children's cumulative durations of MEE in their first 3 years of life and scores on the McCarthy Verbal subscale, and significant positive correlations between durations of MEE and scores on 2 measures of parent-child stress. The percentage of variance in these scores explained by time with MEE beyond that explained by sociodemographic variables ranged from 1.6% to 3.3%. In both the randomized clinical trial and the associational component, sociodemographic variables seemed to be the most important factors influencing developmental outcomes, and in both components, the results at 4 years of age were consistent with the results that had been obtained at 3 years of age. CONCLUSIONS: In otherwise healthy children who are younger than 3 years and have persistent MEE within the duration limits that we studied, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at 4 years of age. In such children, persistent MEE within the duration limits that we studied is negligibly associated with and probably does not affect developmental outcomes at 4 years of age.

Early versus delayed insertion of tympanostomy tubes for persistent otitis media: developmental outcomes at the age of three years in relation to prerandomization illness patterns and hearing levels.

BACKGROUND: Whether prompt insertion of tympanostomy tubes in children with persistent early life otitis media prevents or minimizes subsequent developmental impairment has been the subject of conflicting opinions and differing approaches to management. METHODS: We randomly assigned 429 children with persistent middle ear effusion (MEE) before the age of 3 years to have tympanostomy tubes inserted either as soon as possible or up to 9 months later if MEE persisted. In 402 of these children, we found no significant differences at age 3 years between the 2 treatment groups in mean scores on any measure of speech, language and cognition and in 401 of the children no significant differences in measures of psychosocial development. We then examined outcomes within subgroups of children who might have been the most severely affected, namely those who had been randomized on the basis of bilateral, continuous MEE rather than unilateral and/or discontinuous MEE and those who had the greatest degrees of hearing loss. RESULTS: In none of the subgroups we considered were scores on any outcome measure significantly more favorable in children in the early treatment group than in children in the late treatment group. CONCLUSIONS: In otherwise normal children who have MEE, during the first 3 years of life within the durations we studied, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at age 3 years, irrespective of whether MEE has been continuous or discontinuous and unilateral or bilateral and whether or not MEE has been accompanied by mild to moderate hearing loss.

Hearing levels in infants and young children in relation to testing technique, age group, and the presence or absence of middle-ear effusion.

OBJECTIVE: As part of a prospective study of possible effects of early-life otitis media on speech, language, cognition, and psychosocial development, we evaluated hearing both during episodes of middle-ear effusion (MEE) and when MEE was not present. The objective of this report is to describe age-specific hearing threshold levels in relation to the presence or absence of MEE in a large sample of young children. DESIGN: Participants were 1,055 children drawn from a sample of 6,350 children who were enrolled in the larger study by 2 mo of age. Otologic evaluation of each child was conducted at least monthly. The protocol of the larger study called for hearing evaluations 1) after 8 wk of continuous unilateral or bilateral MEE and every 4 wk thereafter until one test had been conducted when MEE was no longer present; 2) immediately before developmental testing; and 3) in a sample of children without MEE to obtain age-specific normative data. RESULTS: Results are presented by testing technique, age group, and middle-ear condition. In general, hearing threshold levels were highest in the youngest children tested with visual reinforcement audiometry and lowest in the oldest children tested with conventional audiometry. In general also, thresholds were lowest in children with normal middle-ear status, intermediate in children with unilateral MEE, and highest in children with bilateral MEE. On average, the presence of bilateral MEE was associated with hearing threshold levels 10 to 15 dB higher than the normative values for the corresponding age group. CONCLUSIONS: In infants and young children, audiometric results are influenced by testing technique, age group, and the presence or absence of effusion in each ear.