Diane L. Sabo

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 Childrens 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.

Risk Factors for Speech Delay of Unknown Origin in 3-Year-Old Children

One hundred 3-year-olds with speech delay of unknown origin and 539 same-age peers were compared with respect to 6 variables linked to speech disorders: male sex, family history of developmental communication disorder, low maternal education, low socioeconomic status (indexed by Medicaid health insurance), African American race, and prolonged otitis media. Abnormal hearing was also examined in a subset of 279 children who had at least 2 hearing evaluations between 6 and 18 months of age. Significant odds ratios were found only for low maternal education, male sex, and positive family history; a child with all 3 factors was 7.71 times as likely to have a speech delay as a child without any of these factors.

Treatment of children with congenital cytomegalovirus infection with ganciclovir.

Background. Congenital cytomegalovirus (CMV) infection affects ∼1% of live births in the US. Ten percent of these infants have symptoms at birth and another 10 to 15% acquire hearing loss or developmental problems. Congenital CMV is the most common cause of nonhereditary sensorineural hearing loss in children, and progressive hearing loss is common. To arrest the natural progression of congenital CMV, children referred to our center were treated with a prolonged course of ganciclovir. Methods. Medical records of children with congenital CMV who were treated with ganciclovir were reviewed to tabulate their presenting symptoms, duration of treatment, audiologic and developmental assessments and complications Results. We treated nine children with symptomatic CMV with iv ganciclovir at a median age of 10 days (range, 3 days to 11 months). Findings at diagnosis included microcephaly (five of nine); petechiae (five of nine); thrombocytopenia (seven of nine); and intracranial calcifications (six of eight). Hearing loss was noted before therapy in five of nine. The median duration of iv and subsequent oral ganciclovir was 1 year and 0.83 year, respectively. Median follow-up was 2 years (range, 1 to 7 years). No child had progression of hearing loss; improvement occurred in two. Seven children had at least one complication of ganciclovir therapy: central venous catheter/site infection (six); catheter malfunction (three); and neutropenia (one). Conclusion. Of nine children none treated with ganciclovir for congenital CMV had detectable progressive hearing loss. Complications associated with iv therapy occurred frequently. Currently available oral analogues of ganciclovir may facilitate earlier and more prolonged therapy for children with symptomatic congenital CMV and should be subjected to randomized controlled trials.

Identification of otitis media with effusion in children.

In an effort to establish the diagnostic value of otoscopy, tympanometry, and the middle ear (ME) muscle reflex in the identification of otitis media with effusion (OME), the diagnostic findings by these three methods were compared with the findings at myringotomy in 333 children (599 ears). The study showed that even experienced clinicians had some difficulty in identifying those ears with effusion (sensitivity) and had even greater difficulty in making a diagnosis of those ears without an effusion (specificity). However, tympanometry, employing patterns that have been validated with myringotomy findings, was found to be more accurate. On the other hand, assessment of the ME muscle reflex as a diagnostic method was unacceptable due to an extremely low specificity (52%). An algorithm derived from the combination of the three methods had highest sensitivity (97%) and specificity (90%).

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 1055 children drawn from a sample of 6350 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.

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.

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 ≥6 months of age, effusion was diagnosed in only 2.7% of ears with tympanometric height ≥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 ≥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.

Conductive hearing loss in infants and young children with cleft palate

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Reliability of electric response audiometry using 80 Hz auditory steady-state responses

The reliability of the Auditory Steady State Response (ASSR) has not been thoroughly evaluated despite its recent application as a clinical tool for threshold estimation. The purpose of this study was to examine test-retest (TR) reliability of ASSR threshold estimates in an empirical research design. The ASSR, tested using modulation frequencies approximately 80 Hz and above, was evaluated against pure tone audiometry (PTA), and the slow vertex potential (SVP, N1-P2). Sixteen normal-hearing young female adults were tested twice, one week apart. Varying degrees of sensorineural hearing loss of a notched configuration were simulated with filtered masking noise. Test-retest reliability was assessed using Pearson-product moment correlation analysis, supplemented by other post-hoc analyses. Results demonstrated moderately strong TR reliability for ASSR at 1000, 2000 and 4000 Hz (r = 0.83–0.93); however, the reliability of ASSR at 500 Hz was weaker (r = 0.75). Results suggest that ASSR-ERA is a reliable test at mid–high frequencies, at least with the configuration and degrees of simulated sensorineural hearing loss examined in this study.

Validity and accuracy of electric response audiometry using the auditory steady-state response: evaluation in an empirical design.

The validity and accuracy of the application of the auditory steady-state response (ASSR) to electric response audiometry (ERA) was tested further in a study permitting subjects to be their own controls for hearing loss. Simulated sensorineural hearing loss (SSHL) of complex configuration and varying degrees was effected using filtered masking noise. Thresholds estimated via ASSR-ERA were compared to those measured via conventional pure-tone audiometry. Further, the slow vertex potential N1–P2 was recorded to permit a comparison with an evoked-response test of common content validity and known accuracy. Results in a homogeneous subject sample demonstrated strong intertest correlation and agreement within 10 dB at 1000 to 4000 Hz (on average), but not at 500 Hz. The configurations determined by ASSR-ERA followed behavioral audiometric patterns well, except for the mildest degree of SSHL tested. Consequently, limitations of ERA remain, although ASSR-ERA appears to be quite valid overall and promises (justifiably) broad clinical applicability.