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A common ear surgery for children does not measurably improve development at age 3

A new study cosponsored by the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development indicates that in most cases, inserting tubes in the eardrums—a procedure called tympanostomy—of children under age 3 who have fluid in the middle ear has no measurable effect on improving their speech, language, cognitive, or psychosocial development at age 3.

Fluid in the middle ear—otitis media with effusion (OME)—is usually associated with a mild to moderate hearing loss that, although temporary, has been thought by some health professionals to result in long-term impairment of children's development. Approximately 280,000 children under age 3 undergo tympanostomy each year, according to 1996 estimates.

Jack L. Paradise, M.D., and his colleagues at the Children's Hospital of Pittsburgh and the University of Pittsburgh enrolled 6,350 healthy infants from 2 to 61 days of age in the study and evaluated them regularly for middle-ear effusion. Before the age of 3 years, 429 children with persistent effusion were randomly assigned to have tympanostomy tubes inserted either as soon as possible or up to 9 months later if effusion persisted. By age 3, 169 children in the early-treatment group (82 percent) and 66 children in the late-treatment group had received tympanostomy tubes. There were no significant differences between the two groups of children in speech, language, cognition, or psychosocial development. Most of the children in the early-surgery group received surgery within 60 days, whereas most in the late-surgery group either received surgery after more than 6 months or had not received surgery by age 3. The study was conducted between May 1991 and December 1995.

On the General Cognitive Index of the McCarthy Scales of Children's Abilities, the children in the early-surgery group tested at 99, and the children in the late-surgery group tested at 101; both scores are in the average range. On a test of the children's expressive language, the children in the early-surgery group scored 124 while the others scored 126, which are average scores. Other assessments used in the study are measures of receptive language, sentence length, grammatical complexity, speech-sound production (pronunciation), parent-child stress levels, and children's behavior.

According to the researchers, these findings should not be applied to children who have experienced OME for longer periods than those studied by the researchers or to children with more severe degrees of hearing loss. Also, they caution that the results of tests when the children reach ages 4 and 6 years may differ from those found at age 3.

In an accompanying editorial, James M. Perrin, M.D., Director, Division of General Pediatrics and Center for Child and Adolescent Health Policy, Massachusetts General Hospital for Children, and a member of AHRQ's National Advisory Council, notes that these findings provide evidence to support the use of a cautious approach in referring young children with middle-ear effusion to receive tympanostomy tubes. Dr. Perrin also points out that this study provides no evidence that the insertion of tubes improves developmental outcomes at the age of 3, although it does decrease the persistence of effusion and reduce short-term hearing loss.

For more information, see "Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of 3 years," by Dr. Paradise, Heidi M. Feldman, Ph.D., M.D., Thomas F. Campbell, Ph.D., and others in the April 19, 2001 New England Journal of Medicine 344, pp. 1179-1187.

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