A Children's Hospital of Pittsburgh study finds that prompt insertion of tympanostomy tubes (small ear tubes) does not improve developmental outcomes of children at 6 years of age as once thought.
Lead investigator Jack L. Paradise, MD, pediatrician and otitis media expert at Children's and professor of Pediatrics and Otolaryngology at the University of Pittsburgh School of Medicine, and fellow researchers found that in otherwise healthy children younger than 3 years of age who have persistent middle-ear effusion, prompt insertion of the tubes did not improve developmental outcomes at age 6. Previously the researchers had reported similar findings in the children in the study at both age 3 and age 4.
Therefore, these new findings, together with the earlier findings, strongly suggest that no intervention is necessary for most children with fluid in their ears.
The study, is published in the Aug. 11 issue of the New England Journal of Medicine.
Dr. Paradise and his team enrolled 6,350 healthy infants younger than 62 days of age and evaluated them regularly for middle-ear effusion. Before 3 years of age, 429 children with persistent middle-ear effusion were randomly assigned to have tympanostomy tubes inserted either promptly or up to nine months later if effusion persisted.
According to Dr. Paradise, previous studies by other investigators had suggested possible links between long periods of middle-ear fluid during children's first few years of life and various impairments of their speech, language, learning skills and behavior, but those studies as a whole had many limitations and were not convincing.
Dr. Paradise's study, which was primarily supported by the National Institutes of Health, found that in children who had persistent middle-ear effusion during their first three years of life, prompt insertion of tympanostomy tubes had no demonstrable beneficial effect on their developmental outcomes not only at ages 3 and 4 but also at age 6.
"Given the concerns about developmental consequences of persistent middle-ear fluid, and given the demonstrated effectiveness of tube insertion, it is easy to understand why many professionals have advocated screening of seemingly well children and surgical intervention in those found to have persistent fluid," said Dr. Paradise. "Our study has found that no intervention seems necessary for most children with fluid in their ears. Tube insertion performed solely to relieve persistent middle-ear fluid does not appear to improve developmental outcomes in infants and toddlers who are not otherwise at risk."
At 6 years of age, 85 percent of children in the early-treatment group and 42 percent in the delayed-treatment group had received tympanostomy tubes. No significant differences favoring the early treatment group were found on any of the 30 measures of intelligence, speech, language and behavior studied in the clinical trial.
These data, together with risks posed by tube insertion, provide clear support for managing the treatment of such children conservatively, since the fluid almost always clears up spontaneously, Dr. Paradise said. Final testing of the children at age 9 to 11 years has recently been completed, and analysis of those results is currently under way.
So, which children should receive tubes?