New research shows that hospital stays for infants diagnosed with bronchiolitis, or inflammation of the lungs, and treated with nebulized 3% hypertonic saline (HS), a commonly used, off-label therapy, were not shorter than hospital stays for infants who received normal saline solution. Both treatments are liquid salt solutions that are vaporized and administered through a mask; however HS has a greater salt concentration and is believed to more effectively hydrate the air passages, decrease fluid accumulation and improve lung function.
Preliminary data from this first-of-its-kind trial were presented today by researchers at The Children's Hospital at Montefiore (CHAM) at the Pediatric Academic Societies (PAS) Annual Meeting in Washington, D.C.
Bronchiolitis is the leading cause of hospitalization for infants under one year of age in the United States. It causes increased mucus production, coughing, wheezing, shortness of breath and, in some cases, difficulty feeding. More than 150,000 infants are hospitalized each year, on average for three days, costing the healthcare system $500 million dollars annually. Bronchiolitis is often associated with the development of asthma later in life -- one of the most prevalent conditions in the pediatric population.
In this prospective double-blind study, 127 participants aged between 0-12 months were randomly assigned to Group A (n=63) and Group B (n=64), with one group receiving 4ml of nebulized HS and the other receiving normal saline every four hours until discharge. There was no significant difference between length of stay between the two groups (Group A=2.2 vs. Group B=2.0), and rates of adverse events were similar (Group A=18 vs. Group B=14). Calls were made one week and one month after hospital discharge to determine whether patients had been readmitted with repeat symptoms. There were no significant differences between the groups.
"Our preliminary findings suggest that off-label use of nebulized 3% hypertonic saline to treat bronchiolitis may not be beneficial in reducing length of hospital stay," said Alyssa Silver, M.D., attending physician, department of pediatrics, section of pediatric hospital medicine, CHAM and assistant professor of pediatrics, Albert Einstein College of Medicine of Yeshiva University. "These data suggest that a more effective treatment is required to help alleviate symptoms for patients, reduce hospitalization and therefore reduce overall healthcare costs. We believe the full data set will support our findings presented today."
In addition to the primary endpoint of length of stay, the study also investigated the need for patients receiving HS to use an inhaler in order to relax the muscles of the airways and help make it easier to breathe. An inhaler was not used in this study, and data showed there was no increase in rates of readmission or adverse events. This is the first time a U.S. study has examined the safety of HS treatment without the accompanying inhaler.
"Ultimately, the data to date have shown that using a more cost-effective treatment such as normal saline rather than nebulized 3% hypertonic saline, with or without an inhaler, results in equivalent outcomes for infants with bronchiolitis," Dr. Silver said. "As the healthcare system faces major budget concerns, we believe this is one area where cuts can be made by simply reducing the need for the inhaler and finding new approaches to further reduce the length of stay for these infants."
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