Early insertion of ear tubes in otherwise healthy infants and young children with persistent fluid in the middle ear does not improve developmental outcomes up to 9 to 11 years of age, according to results of an important study at Children’s Hospital of Pittsburgh of UPMC led by otitis media researcher Jack Paradise, MD.

These findings strongly suggest that no intervention is necessary for most children with fluid in their ears. Results of the study are published in the New England Journal of Medicine.

Dr. Paradise and colleagues have conducted a longitudinal study of 6,350 children enrolled before the age of 2 months between 1991 and 1995. Among the group of those children who developed persistent middle ear fluid before age of 3 years, the researchers found no evidence that prompt insertion of ear tubes improves developmental outcomes compared with delayed insertion if the fluid eventually fails to clear up spontaneously. This finding reverses a decades-old belief held by many in the medical community that fluid in the middle ear may lead to developmental impairment.

“These findings provide strong evidence that fluid persisting in the middle ear for periods as long as we studied does not affect developmental outcomes in children as old as 11 and that for otherwise healthy children with middle ear effusion, placement of ear tubes is ordinarily not necessary,” said Dr. Paradise, a longtime pediatrician at Children’s and professor emeritus of Pediatrics at the University of Pittsburgh School of Medicine.

Among children in the United States, otitis media is the most commonly diagnosed illness after the common cold. About 90 percent of children have at least one episode of otitis media by the time they are 3 years of age. The term “otitis media” refers both to ear infections and to fluid in the ear that follows ear infections or can lead to ear infections. Otitis media is inflammation in the lining of the middle ear cavity and usually occurs as a complication of a cold or other respiratory infection. The placement of ear tubes, because of either repeated infections, or persistent fluid or both, is the second most common surgery (next to circumcision) among children in the United States.

About 75 percent of children have at least one episode of otitis media by the time they are 3 years of age. Nearly half of these children have three or more episodes by the time they are 3.

Previously published study results by Dr. Paradise, an internationally recognized as a pioneer in pediatric primary care research, and colleagues also showed that prompt insertion of ear tubes in children with middle ear effusion also did not improve developmental outcomes at age 6 or at ages 3 and 4.

Previous studies by other investigators reported had warned that hearing loss associated with persistent otitis media in young children might result in long-term impairment of their development.

Because of this, official guidelines were developed recommending that young children with middle ear effusion lasting for as long as three or four months undergo insertion of ear tubes to clear the fluid and return the hearing to normal.

However, these previous studies, because of their design, established no cause-and-effect relationship between otitis media and developmental impairments, according to Dr. Paradise.

His cumulative findings played an important role in the 2004 decision by the American Academy of Pediatrics, the American Academy of Family Physicians and the American Academy of Otolaryngology – Head and Neck Surgery to revise these guidelines for the insertion of ear tubes.

Before 3 years of age, 429 children in Children’s ear study with persistent effusion were randomly assigned to undergo ear tube insertion either promptly or up to nine months later if effusion persisted. Researchers assessed literacy, attention, social skills and academic achievement in 391 of these children at 9 to 11 years of age in the most recent component of the study.

At the time of testing, 84 percent of the children in the early-treatment group and 45 percent of the children in the delayed-treatment group had undergone insertion of ear tubes. There were no significant differences between the two groups in 48 different developmental measures.

These findings, coupled with the relatively minor risk associated with ear tube surgery, provide clear support for conservative management of fluid in the middle ear, as the fluid almost always clears up spontaneously, according to Dr. Paradise.

“Our recommended treatment approach for children under age 3 in whom fluid has persisted for three months in both ears or four to five months in one ear now calls for watchful waiting for at least six additional months when fluid is present in both ears and for at least nine additional months when fluid is present in only one ear,” he said.

His contributions have advanced pediatric medicine worldwide in the diagnosis and treatment of common childhood diseases, most notably diseases and disorders of the ears, tonsils and adenoids. His primary areas of research have involved investigation of indications for tonsillectomy and adenoidectomy and the management of middle-ear disease. His studies of these conditions have gained him international recognition.

Among his studies of otitis media, Dr. Paradise discovered the near universality of the disease in infants and young children with cleft palate. He also helped establish the use of tympanometry, a noninvasive test to determine the presence or absence of middle-ear abnormalities. Tympanometry has since become a standard diagnostic procedure in primary care pediatrics and an important tool in clinical studies of otitis media.

Children who get frequent infections, such as ear infections, sinusitis or pneumonia, may have a more severe condition called immunodeficiency, according to the American Academy of Allergy, Asthma & Immunology (AAAAI).

Patients who have immunodeficiency have infections that usually do not go away without using antibiotics and often recur within one or two weeks after antibiotic treatment is completed. These patients frequently need many courses of antibiotics each year to stay healthy. There are several forms of immunodeficiency and while some are very severe and life-threatening, many are milder but still important enough to cause recurrent or severe infections.

“People with immunodeficiency get the same kinds of infections that other people get ear infections, sinusitis and pneumonia,” said Jordan Orange, MD, PhD, FAAAAI, Chair of the AAAAI’s Primary Immunodeficiency Diseases Committee. “The difference is that their infections occur more frequently, and are often more severe, and have a greater risk of complications.”

Allergist/immunologists often use the frequency of the use of antibiotics to mark the frequency of significant infections. General guidelines for determining if a patient may be experiencing too many infections are:

– The need for more than four courses of antibiotic treatment per year in children or more than two times per year in adults.

– The occurrence of more than four new ear infections in one year after four years of age.

– The development of pneumonia twice over any time.

– The occurrence of more than three episodes of bacterial sinusitis in one year or the occurrence of chronic sinusitis.

– The need for preventive antibiotics to decrease the number of infections.

– Any unusually severe infection or infections caused by bacteria that do not usually cause problems in most people at the patient’s age.

When to see an allergy/asthma specialist

If your child has any of these conditions, consult with an allergist/immunologist for more information on recurrent infections, immunodeficiency, proper diagnosis and treatments.

The AAAAI’s How the Allergist/Immunologist Can Help: Consultation and Referral Guidelines Citing the Evidence provide information to assist patients and health care professionals in determining when a patient may need consultation or ongoing specialty care by the allergist/immunologist. Patients should see an allergist/immunologist if they:

Have chronic or recurrent infectious rhinosinusitis.

Have any of the following warning signs:

– Eight or more new infections within one year.

– Two or more serious sinus infections within one year.

– Two or more months on antibiotic with little or no effect.

– Two or more pneumonias within 1 year.

– Failure of an infant to gain weight or grow normally.

– Recurrent deep skin or organ abscesses.

– Persistent thrush in mouth or elsewhere on skin after age 1 year.

– Need for intravenous antibiotics to clear infections.

– Two or more deep seated infections.

– A family history of immune deficiency.

For the first time a systematic study which has just been published by epidemiologists of the GSF – Research Center for Environment and Health together with Dutch scientists finds associations between the onset of middle ear infections during the first two years of life and traffic-related air pollutants to which they are exposed.

In view of the fact that on the one hand air pollutants generated by traffic are a permanent source of pollution and on the other hand inflammations of the middle ear are one of the most freqeuent acute infections in young children with many different late consequences to their health, these findings have also significance for the health risk assessment of exposure to ambient fine particles.

It has long been known that environmental factors, such as passive smoking, may also have an influence on the development of otitis media, acute infection of the middle ear, in young children. Little had been known, however, about possible connections with pollutants in the ambient air. Together with scientists from the Dutch universities of Utrecht, Rotterdam, Groningen and Bilthoven Dr. Joachim Heinrich and Prof. Dr. Dr. H.-Erich Wichmann from the GSF – Institute of Epidemiology now first investigated systematically this question in a comprehensive study. Heinrich and his colleagues recorded prenatal data of 4150 Dutch children and 670 children from the Munich LISA study in two prospective studies back in 1997 to 1999 starting at the time of the pregnancy.

On the basis of air pollution measurements the individual exposure was assessed for each child, including nitrogen dioxide and fine particles in the PM 2.5 range. When the parents were interviewed, Heinrich obtained detailed information on the occurrence of inflammations of the middle ear in the children included in the study from birth until the age of two. Other potential risk factors, such as social influences, parental allergies or passive smoking, were also enquired.

The result was amazing even for the scientists themselves: “Both in the Dutch and in the German populations studied we found clear associations between the occurrence of otitis media and the exposure of the children to traffic-related air pollutants,” says Joachim Heinrich from the GSF.

The results in detail: approx. 35 per cent of the children of both cohorts had an acute inflammation of the middle ear at least once in their first two years. The adjusted odds ratios, calculated parameters for a statistical association, are 1.13 and 1.24 for the Dutch and the German cohorts, respectively, for an increment of the PM 2.5 fine particle concentration by 3 micrograms per cubic meter (ug/m3) and exactly 1.14 for an increment of the nitrogen dioxide pollution (NO2) by 10 ug/m3 in both studies. This corresponds to a 13 – 24 per cent higher risk of otitis for a moderate increase in fine particles by 3 ug/m3 as well as a 14 per cent higher risk for an increase in NO2 by 10 ug/m3.

The scientists suspect that the same mechanism is responsible for the association between air pollutants and otitis as is assumed for the known association between passive smoking and otitis: Elevated ambient air pollution causes inflammations in the airways and restricts the functionality of the cilia in the upper airways. They are responsible for the removal of inhaled particles, their reduced functionality has been shown to increase the risk of respiratory infections – one of the known causes for the development of middle ear infections.

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References:

Brauer, M. et al. (2006): Traffic-Related Air Pollution and Otitis Media
Environmental Health Perspectives Vol.114, No.9:1414-1418

GSF – Forschungszentrum fur Umwelt und Gesundheit
http://www.gsf.de

A multicenter study on treating common ear infections in children with ear tubes adds to a growing body of evidence that favors antibiotic ear drops over antibiotics swallowed in pill or liquid form in such cases, a UT Southwestern Medical Center researcher reports.

The latest study, involving 80 children, showed that antibiotic ear drops performed better and faster in treating middle ear infections in children with ear tubes than merely taking oral antibiotics such as swallowing a pill or liquid. The findings are available online in the journal Pediatrics.

“With the use of ear drops, you can put more potent medicine just where you need it,” said Dr. Peter Roland, chairman of otolaryngology at UT Southwestern and one of the study’s authors.

The latest study looked at children ages 6 months to 12 years who had ear tubes, middle ear infections, and visible drainage in the ear. Both the oral and topical antibiotics cure the infections in more than 70 percent of cases. But the topical drops resolved the ear drainage three to five days faster and resulted in more clinical cures overall – 85 percent for those taking drops, compared to 59 percent for oral administration of medication – according to the study.

That-s in line with previous research and other findings that support increased use of topical antibiotics over oral antibiotics in other cases involving middle ear infections, one of the most common childhood afflictions, said Dr. Roland, who heads the Clinical Center for Auditory, Vestibular and Facial Nerve Disorders at UT Southwestern and who is also chief of pediatric otology at Children-s Medical Center Dallas.

Middle ear infections are the most common diagnosis for which children receive antibiotics, and insertion of ear tubes is the most common surgery performed on children.

Many doctors treat these infections with oral antibiotics like amoxicillin, which is absorbed through the blood stream, said Dr. Roland.

The tubes, researchers reported, provide better access to the middle ear, behind the ear drum, so more of the ear drops medicine reach the infection, avoiding potential intestinal and blood absorption that occurs with oral antibiotics. Researchers discovered that the concentration at the infection can be a thousandfold greater than when oral or IV medication is used.

In addition, because the antibiotic is not distributed throughout the body, there is less chance of developing antibiotic resistance.

Dr. Roland has previously demonstrated that middle ear infections are often caused by micro-organisms that are not susceptible to antibiotics approved for pediatric patients. But the ear infections are sensitive to topical ear drops. That research showed that children with ear tubes have different micro-organisms than those without the tubes, thereby requiring different treatment.

Previous research has shown other advantages to topical antibiotics for middle-ear infections as well:

* They tend to be more tolerable for children, so parents are more likely to comply with the whole regimen.

* They tend to cause fewer gastrointestinal problems, such as diarrhea, gastroenteritis, dermatitis or complications from yeast infections than the oral antibiotics.

* They lead to less antibiotic resistance, a major goal of the Centers for Disease Control and Prevention since 1995.

Queensland has been gripped by one of the worst flu seasons in years, leaving many patients with secondary bacterial infections.

Despite, the Australian Medical Association urging people to be vaccinated against the flu every year, many don’t take heed. And if luck doesn’t prevail and an infection develops antibiotics become the treatment of choice.

However, behind the scenes a number of Queensland researchers are developing alternative precautions that one day may see a preventative immunisation or better still a non-invasive protection against a range of respiratory bacterial infections.

Central Queensland University’s Pro Vice-Chancellor (Research and Innovation) Professor Jennelle Kyd is leading a team of researchers in Rockhampton, in Central Queensland, and collaborating with many across Australia, Europe and the USA including pharmaceutical companies on the research and development of patents to the clinical trials stage for a range of new therapies.

“We currently treat respiratory infections with antibiotics, but we need to find better preventative therapies otherwise we’ll continue to increase the emergence of bacteria that are drug resistant. Vaccines offer the best strategy for long term prevention of infections,” Professor Kyd explained.

Middle ear infection is one of the most common conditions in children with over 70% suffering in the first few years of life.

The same bacteria are responsible for many respiratory conditions, but also exist as part of the normal nasal bacterial flora.

Professor Kyd said while the new paediatric pneumococcal vaccine targets some of the problem bacteria, there is a gap in vaccine coverage, meaning that children still become infected by the other bacteria that cause the same type of infection.

“The current vaccines and some more recent clinical trials with a newer formulation have demonstrated that it is possible to reduce the number of infections caused by some of these bacteria and adding other components could make a much greater impact on reducing respiratory and middle ear bacterial infections.”

The Capricornia Centre of Mucosal Immunology, under the leadership of Professor Kyd, is developing new vaccines and non-injection type delivery for bacterial infection protection.

Australian indigenous children have one of the highest incidence rates in the world, with many becoming chronic sufferers resulting in persistent effusions, ruptured ear drums and hearing loss at a crucial stage in their development.

“We are also trying to identify why Indigenous kids are even more prone to middle ear infections. A controlled study has shown that socio-economic reasons do not fully explain this propensity, and many of our indigenous children succumb to middle ear infections at an earlier age and go on to suffer serious recurrent or chronic middle ear infections,” Professor Kyd said.

For parents, 8 million cases of acute middle ear infections every year add up to a lot of sleepless nights and trips to the pediatrician. But new research from a collaboration between Rockefeller University and St. Jude Children’s Hospital could change all that.

In PLoS Pathogens, Rockefeller’s Vincent A. Fischetti and colleagues at St. Jude show that middle ear infections in mice can be prevented by giving the mice a lysin – a protein derived from a virus that infects bacteria. The new technology may prevent children with the flu from developing secondary ear infections and would be an attractive alternative to traditional antibiotics, to which bacteria are rapidly becoming resistant.

The bacteria that cause middle ear infections, Streptococcus pneumoniae, aren’t transmitted at school. They already reside on the mucosal membranes in the nose, waiting for their chance to strike. When a child catches the flu, or another virus that causes an upper respiratory infection, the bacteria seize the opportunity and migrate to the middle ear, causing a secondary infection. The new treatment would kill the bacteria before it had a chance to move.

“These bacteria take advantage of a viral infection by striking when our resistance is lowered,” says Fischetti, head of Rockefeller’s Laboratory of Bacterial Pathogenesis and Immunology. “You should start taking an antibiotic the moment you come down with the viral infection to prevent the secondary infection, but physicians are reluctant to do this for fear of increasing resistance to antibiotics. So we’re really in a catch-22 situation.”

Fischetti’s lab has done extensive research on lysins, which are proteins derived from viruses that normally infect bacteria. After a virus has infected the bacteria and replicated, it uses lysins to punch holes in the bacteria’s cell wall, killing the bacteria, in order to escape. Fischetti’s lab has studied many different lysins and found that they work even from outside the bacterial cell as well as from the inside. In addition, unlike antibiotics, which kill many of the body’s beneficial bacteria along with the disease-causing ones they target, lysins are highly specific. Each lysin will only kill a specific type of bacteria, leaving the body’s normal flora untouched.

“We knew from our previous experiments that if you treat an animal infected or colonized with pneumococci or streptococci with these lysins, you could cure or decolonize them,” says Fischetti. “But I was looking for a way to see if lysins would work for secondary infections too, and John McCullers had a very nice model system.”

The two researchers collaborated – Fischetti sent McCullers, a physician at St. Jude Children’s Hospital Department of Infectious Diseases, the lysin, and McCullers tested his mice. He colonized his mice with S. pneumoniae, treated some of them with the lysin and then gave them all influenza. Eighty percent of the mice that did not receive the lysin came down with middle ear infections, but none of the mice given the lysin did. The treatment was 100 percent effective.

“It is really a no-brainer experiment,” says Fischetti. “If the bacteria aren’t there, they cannot cause the secondary infection.”

“Secondary bacterial infections cause much of the sickness and about 25 percent of all deaths during flu season,” says McCullers. “Eliminating these secondary infections could dramatically reduce sickness and death rates.”

According to an Article in this week’s issue of The Lancet, antibiotics for middle ear infection (otitis media) are only beneficial in children under the age of two with both ears infected. For most other children an observation policy seems justified finds the study.

Otitis media occurs when the middle ear, behind the eardrum, becomes inflamed. It is one of the most common childhood infections and causes pain and fever. Currently, in most countries children aged less than two years receive antibiotics when they have acute otitis media. But the latest research shows that only some of these children actually benefit from this treatment.

In the study Maroeska Rovers (University Medical Center Utrecht, Utrecht, Netherlands) and colleagues combined the data from six randomised trials assessing the effectiveness of antibiotics on otitis media, involving over 1600 children. They found that the effect of antibiotics on pain and fever was modified by age, by infection in both ears, and by the presence of otorrhoea (discharge from the ear). The results showed that for children younger than two years with otitis media in both ears, four would have to be treated with antibiotics to prevent an extended course of the disease in one child. However, in children older than two, with infection in both ears, nine children would have to be treated to prevent one extended case. For children younger than two with infection in one ear, 20 would have to be treated. The study also found that antibiotics were more beneficial in children with otorrhoea than those without irrespective of age.

The researchers believe this may be because the infection is more often bacterial than viral in children aged less than 2 years with bilateral severe otitis media and in those with otorrhoea.

Study author, Dr Heather Winskel, from the University’s School of Psychology, says middle ear infection or otitis media (OM) is the most common childhood illness.

“At least 70% of children are likely to experience at least one episode of otitis media before they are three-years-old and for many children it is a recurrent problem,” says Dr Winskel.

“The peak incidence of OM occurs when children are between 6 and 18 months, which is the most critical period of language development, when the infant is tuning in to the speech sounds that characterise their native language. This process allows young children to break into the stream of speech and eventually map sound onto meaning.

“Fluctuating hearing loss due to OM during the early years of life presents the child with an intermittent speech signal that is difficult to process.”

According to Dr Winskel, while earlier studies have indicated that ongoing middle ear infections in young children appear to be linked with poor language and literacy skills these studies have also produced conflicting results.

“This study attempts to address the shortfalls of earlier research by using a variety of language and reading measures which allow us to ascertain which particular levels or aspects of language and reading are affected by an early occurrence of OM.”

The project compared two groups of children aged between 6 and 8 years from schools across western Sydney – 43 children with an early history of repeated episodes of OM before the age of three and a control group of 43 children matched for chronological age, gender and socio-economic status.

Children were tested on three different linguistic levels – phonological awareness, semantic knowledge and narration and reading ability.

Dr Winskel says the findings support the view that if a child experiences OM during the crucial first years of life, it may have long-term effects on subsequent language and literacy development.

“There was a general tendency for children with a history of OM to achieve lower scores on phonological awareness skills of alliteration, rhyme and non-word reading, semantic skills of expressive vocabulary and word definitions and reading compared to non-OM children,” she says.

“Extensive research has indicated that phonological awareness is a necessary skill children need to begin reading.

“It appears that although some speech and language deficits may be overcome with age, other effects have the potential to persist beyond the pre-school years.”

For children with acute ear infections seen in an emergency department, giving parents the option of delaying use of antibiotics resulted in significantly lower use of antibiotics compared to parents who received a standard prescription, with little difference in the outcomes for the children, according to a study in the September 13 issue of JAMA.

Acute otitis media (AOM; ear infection) is the most common reason for which an antibiotic is prescribed to children. Treatment of AOM accounts for an estimated 15 million antibiotic prescriptions written per year in the United States, according to background information in the article. Untreated AOM has a high rate of natural resolution, with similar rates of complications whether antibiotics are prescribed or withheld. Resistance to antibiotics is a major public health concern worldwide and is associated with the widespread use of antibiotics.

David M. Spiro, M.D., M.P.H., formerly of the Yale University School of Medicine, New Haven, Conn., and colleagues conducted a study to determine whether treatment of AOM using a “wait-and-see prescription” (WASP) significantly reduced use of antibiotics compared with a “standard prescription” (SP), and evaluated the effects of this intervention on clinical symptoms and adverse outcomes. Overall, 283 children with AOM aged 6 months to 12 years seen in an emergency department were randomly assigned to receive either a WASP (n = 138) or a SP (n = 145). All patients received ibuprofen and ear analgesic drops for use at home. Phone interviews were conducted after enrollment to determine outcomes. The trial was conducted between July 2004 and July 2005.

The researchers found that the WASP significantly reduced the use of antibiotics. Substantially more parents in the WASP group did not fill the antibiotic prescription, compared to the SP group (62 percent vs. 13 percent). There was no statistically significant difference between the groups in the frequency of subsequent fever, otalgia (ear ache), or unscheduled visits for medical care. The patients in the WASP group whose parents filled the prescription reported they did so because of fever (60 percent), otalgia (34 percent), or fussy behavior (6 percent). No serious adverse events were reported for patients in the study.

“This randomized controlled trial has provided evidence that the WASP strategy significantly reduces the use of antibiotics in an urban population presenting to an emergency department and may be an alternative to routine treatment of AOM with antibiotics. Wait-and-see prescriptions remain controversial as most pediatricians in the United States have been trained to routinely prescribe antibiotics for AOM and believe that many parents expect a prescription; a small minority of practitioners who care for children routinely use watchful waiting.

“The WASP approach may interrupt the cycle of antibiotic prescription, the expectation of parents to immediately treat AOM with an antibiotic, and subsequent medical visits for this illness. The risks of antibiotics, including gastrointestinal symptoms, allergic reactions, and accelerated resistance to bacterial pathogens must be weighed against their benefits for an illness that, for the most part, is self limited. The routine use of WASP for AOM will reduce both the costs and adverse effects associated with antibiotic treatment and should reduce selective pressure for organisms resistant to commonly used antimicrobials,” the authors conclude.

Inserting a “shield” of cartilage into the inner ear is a less invasive and more cost-effective alternative to membrane reconstruction when treating hearing loss in selected patients suffering from chronic middle ear infections (otitis media), according to a new study published in the June 2007 edition of Otolaryngology Head and Neck Surgery.

The study’s authors determined that by inserting a Type III cartilage shield through tympanoplasty as a way to replace damaged tympanic membranes, patients with hearing loss of this kind will experience, on average, an 11.22 decibel (dB) improvement in hearing quality. The study monitored 52 patients treated with a cartilage shield insertion over a seven year period.

According to the study’s authors, the method achieved results similar to reconstructing the tympanic membrane through alloplastic partial ossicular prostheses (PORPs); however, inserting PORPs is considered more invasive and costly, and in some cases not a viable option.