Jack L. Paradise

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.

Treatment of Acute Otitis Media in Children under 2 Years of Age

BACKGROUND Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media. METHODS We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure. RESULTS Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae. CONCLUSIONS Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).

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.

Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial

To determine the efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion in preventing recurrences of acute otitis media, we randomized 264 children 7 to 35 months of age who had a history of recurrent otitis media but were free of middle ear effusion to receive either amoxicillin prophylaxis, bilateral tympanostomy tube insertion or placebo. The average rate of new episodes per child year of either acute otitis media or otorrhea was 0.60 in the amoxicillin group, 1.08 in the placebo group and 1.02 in the tympanostomy tube group (amoxicillin vs. placebo, P < 0.001; tubes vs. placebo, P = 0.25). The average proportion of time with otitis media of any type was 10.0% in the amoxicillin group, 15.0% in the placebo group and 6.6% in the tympanostomy tube group (amoxicillin vs. placebo, P = 0.03; tubes vs. placebo, P < 0.001). At the 2-year end point, the rate of attrition was 42.2% in the amoxicillin group, 45.5% in the placebo group and 26.7% in the tympanostomy tube group. Adverse drug reactions occurred in 7.0% of the amoxicillin group and persistent tympanic membrane perforations developed in 3.9% of the tympanostomy tube group. The observed degree of efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion must be viewed in light of the fact that study subjects proved not to have been at as high risk for acute otitis media as had been anticipated and in view of the differential attrition rates. We conclude that in the age group we studied, amoxicillin prophylaxis is the preferred first measure in attempting to prevent recurrences of acute otitis media and that tympanostomy tube insertion is a reasonble next alternative.

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.

Consequences of unremitting middle-ear disease in early life. Otologic, audiologic, and developmental findings in children with cleft palate.

To learn whether chronic otitis media with effusion during early life has lasting otologic, audiologic, or developmental consequences, we evaluated 24 closely matched pairs of children with repaired palatal clefts whose treatment had been equivalent except with regard to persistent otitis media during early life. One group had undergone early (mean age, 3.0 months) myringotomy with placement of tympanostomy tubes, followed by assiduous monitoring and an aggressive treatment program to maintain ventilation in the middle ear. The other group had undergone initial myringotomy later (mean age, 30.8 months) or not at all (two subjects) and presumably had had continuous middle-ear effusion throughout most or all of the first few years of life. Eardrum scarring was equal in both groups. Hearing acuity and consonant articulation were impaired in both groups, but hearing acuity was less impaired (P = 0.05 to 0.10) and consonant articulation significantly less impaired (P = 0.03) in the group undergoing early myringotomy. Mean verbal, performance, and full-scale IQs and scores on psychosocial indexes were normal in both groups and did not differ significantly between the groups. These findings support the hypothesis that early, longstanding otitis media may result in impairment of hearing and of speech, but they do not support the hypothesis that cognitive, language, and psychosocial development are adversely affected.

1. Definitions, Terminology, and Classification of Otitis Media:

The 1978 task force did not include grading of acute otitis media and otitis media with effusion, related to severity, or a classification of the complications and sequelae of otitis media, and related conditions, in their deliberations. Many of the terms were defined before the advent of modern otology, which has afforded us the opportunity to examine patients with the operating microscope, both in the ambulatory setting and at the time of otologic surgery. Also, the recent availability of radiologic imaging technology has allowed us to visualize contents of the temporal bone and the intracranial cavity that were not accessible to the pioneers in otology.

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 influenzaein 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.

Eustachian Tube Ventilatory Function in Relation to Cleft Palate

The ventilatory function of the Eustachian tube was assessed in a group of infants and children with cleft palate, some of whom had received palatal repair. Those whose palates had been repaired were better able, in general, to equilibrate applied positive middle ear pressures than were those with open clefts. In many of the patients whose palates had been repaired, the results of Eustachian tube function studies were similar to those in normal subjects. Differences in Eustachian tube ventilatory function are assumed to be related to differences in tubal compliance. Excessive compliance probably results in, or exaggerates, functional Eustachian tube obstruction. Improvement in tubal function following palate repair is probably related to factors resulting in greater tubal stiffness.

History of recurrent sore throat as an indication for tonsillectomy. Predictive limitations of histories that are undocumented.

As part of a prospective study of indications for tonsillectomy and adenoidectomy, we followed closely 65 children with histories of recurrent throat infection that seemed impressive (at least seven episodes in one year, five in each of two consecutive years or three in each of three consecutive years), but lacked documentation. During the first year of observation, only 11 children (17 per cent) had episodes of throat infection with clinical features and patterns of frequency conforming to those described in their presenting histories. Of the remaining 54 children, 43 (80 per cent) experienced no, one or two observed episodes each, and most of the episodes were mild. We conclude that undocumented histories of recurrent throat infection do not validly forecast subsequent experience and hence do not constitute an adequate basis for subjecting children to tonsillectomy.