Study: Implanting ear tubes in children doesn't improve development

Thursday, April 19th 2001, 12:00 am
By: News On 6

Implanting ear tubes _ an operation done on hundreds of thousands of toddlers each year _ does not appear to improve their speech and learning development and may not be worth the risks and the cost, a study suggests.

The tiny tubes are inserted in the eardrums to help clear the fluid that can build up in a child's middle ear during an infection and to prevent further infections. Because the fluid can cause hearing loss, there is concern that the child's speech, language and other development will suffer if the fluid persists for weeks or months.

But whether that hearing loss actually harms development is not certain; previous studies have produced inconsistent results.

In a study in Thursday's New England Journal of Medicine, researchers in Pittsburgh looked at two groups of toddlers: those who got ear tubes after three months of fluid in their ears _ the standard guideline _ and those who waited up to nine months before tubes were inserted. The children were tested for speech, language, learning and behavior when they turned 3.

``The bottom line was there wasn't any difference in the developmental outcomes as best we could measure them at age 3,'' said Dr. Jack L. Paradise of Children's Hospital of Pittsburgh.

The study only looked at children who were candidates for tubes because of lingering fluid, not specifically to relieve chronic infections. It was funded by the National Institute for Child Health and Human Development, the Agency for Healthcare Research and Quality and two drug makers, SmithKline Beecham Laboratories and Pfizer.

The researchers cautioned that longer periods of fluid or more severe hearing loss than those studied could affect development and that problems not apparent at age 3 might surface later. Paradise said the children were tested at 4 and the results are being analyzed, and testing at 6 is under way.

The American Academy of Otolaryngology-Head and Neck Surgery estimates that 700,000 children undergo the procedure each year at an estimated cost of $2,000. The tubes have been used since the early 1960s.

Paradise said there is a small risk of complications from the anesthesia. Also, he said, the tubes sometimes leave perforations in the eardrums or scar them, or cause chronic drainage from the ear.

``If tubes were absolutely harmless and free, then I think you might say, `Well, let's have the tubes to be sure,''' Paradise said. ``But tubes themselves carry risk and, of course, there's cost involved. So it becomes a matter of ... which set of risks would you rather take?

Paradise said he would hold off inserting tubes if the only concern was developmental problems from hearing loss.

A New York pediatric otolaryngologist, Dr. Max M. April, said the Pittsburgh study was narrowly focused. He noted that about half of all tubes inserted are because the child has repeated ear infections, and the study did not look at infections.

In addition, ``at age 3, it's very difficult to test developmentally,'' April said. ``And yes, they don't see a difference in waiting. But it's a hard test to make a major statement about.''

``Information at 6 years will be very helpful because at 6 years, first-grade, developmental testing is much more accurate and that will be a very important study,'' he said.

The Pittsburgh researchers enrolled 6,350 healthy infants from 1991 to 1995 and monitored them for ear infections and buildup of fluid. If the fluid persisted for three months, the children were randomly assigned to one of two groups if their parents agreed.

One group got ear tubes right away. The second group waited and got tubes at six months if they still had fluid in both ears or at nine months if fluid remained in one ear.

In all, 402 children from the two groups were tested when they turned 3. The researchers found no significant differences in their development. The researchers also compared the youngsters with children in the study who were not considered for tubes, and again found no difference.

In a related study, researchers in Toronto reported that removing a child's adenoids or tonsils and adenoids when ear tubes are implanted substantially reduces the likelihood of more hospital stays and operations because of ear infections. They said more study is needed to determine which children would benefit most from the additional surgery.