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PITTSBURGH -- Small children with persistent middle-ear effusion who did not get immediate insertion of tympanostomy tubes developed as well as peers given rapid treatment when they grew to ages nine to 11 years, investigators here reported.
PITTSBURGH, Jan. 17 -- Small children with persistent middle-ear effusion who did not get immediate tympanostomy tube insertions were indistinguishable at ages nine to 11 years from peers who were given rapid treatment, investigators here reported.
In a follow-up on the literacy, attention, social skills, and academic achievement of 391 children, ages nine to 11, who had been randomized when they were three or younger to prompt or delayed tube placement, there was no significant difference between the groups in 48 language or behavior scores.
There had also been no significant differences between the groups when the children were three to six years old.
"Accordingly, in children such as those we studied, watchful waiting for at least six additional months when effusion is bilateral and for at least nine additional months when effusion is unilateral is the preferred management option," the investigators wrote. said Jack L. Paradise M.D., of Children's Hospital of Pittsburgh, and colleagues, in the Jan. 18 issue of the New England Journal of Medicine.
The earlier follow-up by Dr. Paradise's group at three, four, and six years of age negated concerns that poor hearing from persistent otitis media would impair cognitive, language, speech, or psychosocial development.
Long-term effects were still a question, though, because finer discrimination among speech sounds may be required for reading and spelling than for speaking, which could contribute to problems at school and in behavior, the researchers said.
The consistent findings for the children at older ages provides "convincing evidence" of a lack of developmental benefit from early tube placement, according to an accompanying editorial by Stephen Berman, M.D., of the University of Colorado and Children's Hospital in Denver.
"These new findings are important because they provide reassurance that developmental impairments that are not identified at an earlier age do not come into play later in the setting of greater academic challenges," he wrote.
The researchers prospectively enrolled 6,350 infants soon after birth and regularly checked them for middle-ear effusion. The 429 with persistent otitis media with effusion before three years of age were randomized to prompt tympanostomy tube insertion or watchful waiting for up to nine months with subsequent tube placement if effusion continued to persist.
The current study analyzed results from a battery of 48 developmental tests for literacy, attention, social skills, and academic achievement administered to 391 of these children at age nine to 11. At that time, 84% of the children in the early-treatment group and 45% of those in the delayed-treatment group had undergone tube insertion.
The researchers found no significant differences in scores for any of the tests favoring early treatment, either before or after adjustment for sex and age on non-normative measures. Comparing the early- and delayed-treatment groups, the findings included:
The only significant difference was higher scores for the early treatment group on the parent's rating of total problems on the Child Behavior Checklist (5112 versus 4912, P
The joint otitis media guidelines by the American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics recommend that physicians perform a hearing test for otherwise healthy children if the effusion persists for three months with monitoring of hearing at three- to six-month intervals until the effusion clears. In cases of bilateral hearing loss of 40 dB or higher, diagnosed speech or language delay, or structural abnormalities of the eardrum, the guidelines recommend placement of tympanostomy tubes.