Developmental Consequence of Otitis Media

Since 1991, Dr. Jack L. Paradise and a group of colleagues from the core and auxiliary faculty of the UCLID Center have been conducting a large, prospective study whose main objectives are to determine whether otitis media with effusion (OME) occurring at common levels of frequency and duration during the first 3 years of life causes impairments of speech, language, cognitive, or psychosocial development, and if so, whether prompt insertion of tympanostomy tubes is efficacious in preventing or lessening the impairments. We enrolled a sociodemographically diverse sample of 6350 healthy children within the first two months of life who had no other risk factors known to affect development [1-5]. We used pneumatic otoscopy to determine the presence or absence of middle ear effusion (MEE) and we systematically monitored the interobserver reliability of otoscopic diagnoses. In addition, we used tympanometry routinely in early phases of the study, and selectively in later phases, to confirm diagnoses or aid in diagnostic decision-making. The sociodemographic diversity of the children was adequate for addressing the independent contributions of SES and MEE on outcomes.

The statistically significant negative associations found in many studies between language skills and the cumulative duration of antecedent MEE might suggest either that persistent early-life MEE had actually caused the later lower scores on developmental tests or, alternatively, that unidentified confounding factors had predisposed children both to early-life OM and to relatively poor performance on the developmental measures.

Help in distinguishing whether OM is a cause of developmental compromise or a marker of developmental risk is provided by the early results of our randomized clinical trial of early versus late or no tympanostomy tube insertion for persistent MEE[2]. Tympanostomy tube insertion is a surgical procedure evacuates fluid from the middle ear and ameliorates the hearing loss associated with MEE. The procedure reduces the number of subsequent bouts of acute OM.

We assigned 429 children who had reached a specified and clinically relevant threshold of persistent MEE to undergo tube insertion either promptly (early-treatment group) or after specified intervals if the effusion persisted (late/no-treatment group). The randomization divided the children into two subgroups who would be expected to differ in their subsequent experience with MEE and hearing status. The strategy was successful in changing the duration of MEE in the 2 groups. In the 402 of these children in whom we assessed speech, language, cognitive, and psychosocial development at age 3 years, we found no significant differences between the early-treatment group and the late/no treatment group in scores on any of the language or other outcome measures used [2]. Moreover, we have seen no difference between groups at ages 4 or 6 [6, 7]. We think it likely that negative associations between language measures and MEE in many reflect confounding factors that contribute, on the one hand, to the duration of OM in young children and, on the other hand, to slow development of their language skills. However, our current thinking is that MEE is not a direct cause of low scores on developmental measures in childhood.

References from the large study [1-11]

1. Feldman, H.M., et al., Parent-Reported Language and Communication Skills at Ages 1 and 2 Years in Relation to Otitis Media in the First Two Years of Life. Pediatrics, 1999. 104(4): p. e52.

2. Paradise, J.L., et al., Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years. New England Journal of Medicine, 2001. 344(16): p. 1179-1187.

3. Paradise, J.L., et al., Language, speech sound production, and cognition in three-year-old children in relation to otitis media in their first three years of life. Pediatrics, 2000. 105(5): p. 1119-1130.

4. Paradise, J.L., et al., Parental stress and parent-rated child behavior in relation to otitis media in the first three years of life. Pediatrics, 1999. 104(6): p. 1264-1273.

5. Paradise, J.L., et al., Otitis media in 2253 Pittsburgh-area infants; Prevalence and risk factors during the first two years of life. Pediatrics, 1997. 99: p. 318-333.

6. Paradise, J., et al., Early vs delayed tube placement for persistent middle-ear effusion (MEE) in the first 3 years of life: Effects on cognition, language, and speech sound production at age 4 years., in SPR/APS/APA Late-Breaker Abstract #4. May 4, 2002: Baltimore MD.

7. Feldman, H., Paradise, JL, Dollaghan, CA, Campbell, TF, Colborn, DK, Pitcairn, DL, Rockette, HE, Janosky, JE, Kurs-Lasky, M., Sabo, DL, Bernard BS, Smith, CG Early vs delayed tube placement for persistent middle-ear effusion (MEE) in the first 3 years of life:, Effects on intelligence, receptive language, and auditory processing at age 6 years., in SPR/APS/APA Late-Breaker Abstract #16. May 7, 2002: Baltimore MD.

8. Ah-Tye, C., J.L. Paradise, and D.K. Colborn, Otorrhea in Young Children After Tympanostomy-Tube Placement for Persistent Middle-Ear Effusion: Prevalence, Incidence, and Duration. Pediatrics, 2001. 107(6): p. 1251-333.

9. Dollaghan, C.A., et al., Maternal education and measures of early speech and language. Journal of Speech, Language, & Hearing Research, 1999. 42(6): p. 1432-43.

10. Feldman, H.M., et al., Measurement properties of the MacArthur Communicative Development Inventories at ages 1 and 2 years. Child Development, 2000. 71(2):310-22(2): p. 310-322.

11. Sabo, D.L. and J.L. Paradise, Hearing assessment of children birth to 3 years of age with and without middle ear effusion. submitted.