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Nebulized 5% or 3% Hypertonic or 0.9% Saline for Treating Acute Bronchiolitis in Infants Khalid Al-Ansari, MD, FRCPC, FAAP(PEM), Mahmoud Sakran, MD, Bruce L. Davidson, MD, MPH, Rafah El Sayyed, MD, Hella Mahjoub, Mahjoub, MD, and Khalid Ibrahim, Ibrahim, MD
compar are e the the efﬁca efﬁcacy cy and and safe safety ty of 5%, 5%, 3%, 3%, and and 0.9% 0.9% sali saline ne solu soluti tion on for for trea treati ting ng acut acute e bron bronch chio ioliliti tiss Objective To comp in the prehospital setting. Study design This was a double-blind trial including consecutive infants aged 3% could be safe and more efﬁcacious, alleviating severe symptoms and avoiding the need f or or hospitalization in some instances. To build on the therapeutic beneﬁt of 3% saline for inpatients with acute bronchiolitis,9-13 we applied the dose-response and safety data from stable patients with cystic ﬁbrosis, cautiously focusing on 5% rather than higher concentrations for our infant patients. We compared 5% saline with 3% saline and 0.9% (normal) saline in terms of efﬁcacy and safety in treating acute bronchiolitis in the outpatient, early treatment*inﬁrmary setting.
Methods We conducted a double-blinded, randomized, parallel-group clinical trial to compare the efﬁcacy and safety of 5% and 3% hypertonic saline versus 0.9% (normal) saline for the treatment of acute bronchiolitis. The study was conICU RSV RSV
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From the Division of Pediatric Emergency Medicine, Department of Pediatrics, Hamad Medical Corporation, Doha, Qatar (K.A., M.S., R.E., H.M., K.I.); Weill Cornell Medical Medical College,Doha, College,Doha, Qatar(K.A.,B.D.); andDivisionof Pulmonary and Critical Care Medicine, University of Washington School of Medicine, Seattle, WA (B.D.) Supported by Hamad Medical Corporation which employs all of the physicians except B.D., who also worked at Hamad. The authors declare no conﬂicts of interest. Registered at clinicaltrials.gov clinicaltrials.gov:: ID# NCT01016249. NCT01016249. 0022-3476/$ - see front matter. Copyright Ó 2010 Mosby Inc. All rights reserved. 10.1016/j.jpeds.2010.04.074
Vol. 157, No. 4 ducted between September 2007 and December 2008 in the short-stay unit of the Pediatric Emergency Center of Hamad General Hospital, the only pediatric emergency facility in Qatar. The center serves an average of 200 000 patients annually and manages 42 beds in a short-stay unit. Patients admitted to the unit are assessed at least every 6 hours by a pediatrician to determine readiness for discharge. The length of stay in the unit for bronchiolitis ranges from 6 to 168 hours. Infants aged #18 months presenting to the unit for the treatment of moderate to severe viral bronchiolitis were eligible for the study. Inclusion criteria were a prodromal history consistent with viral upper respiratory tract infection followed by wheezing and/or crackles on auscultation and a Wang bronchiolitis severity score16 of $4 (Table I; available at www.jpeds.com) on presentation. Patients were excluded from the study if they had one or more of the following characteristics: born at #34 weeks’ gestation, previous history of wheezing, steroid use within 48 hours of presentation, obtundation and progressive respiratory failure requiring intensive care unit (ICU) admission, history of apnea within 24 hours before presentation, oxygen saturation #85% on room air at the time of recruitment, history of a diagnosis of chronic lung disease, congenital heart disease, or immunodeﬁciency. The 6 attending physicians covering the 18 beds in the respiratory section of the shortstay unit were trained on using the Wang bronchiolitis severity score and its practical application on 4 patients with bronchiolitis before the start of the study. Written informed consent, sought from a parent or legal guardian as soon as the patient was admitted to the unit, was obtained for every participant. The study was approved by the hospital’s Institutional Review Board. Study Procedures Patients were examined on presentation in the Pediatric Emergency Center’s examination area, and those needing further treatment or observation were admitted to the short-stay unit. Patients with bronchiolitis were assessed for study eligibility within 2 hours of the initial physician assessment. In patients for whom consent was obtained, plain chest radiography was performed, and nasopharyngeal swabs were taken for detection of respiratory syncytial virus (RSV) (RSV Respi-Strip; Coris Bioconcept, Gembloux, Belgium). Then a computer-generated list of random numbers was used by the enrolling physicians in consecutive order to identify a sealed envelope containing 1 of 3 codes identifying 1 of 3 different 500-mL bags of sterilely prepared blinded study solution containing 5%, 3%, or 0.9% saline, prepared fresh each morning by a pharmacist blinded to patient assignment. Patients received 5mL of the study nebulization mixed with 1.5 mL of epinephrine in a double-blinded fashion on enrollment and every 4 hours thereafter until they were ready for discharge. Inhaled medications were delivered through a tight-ﬁtting face mask by pressurized oxygen with the ﬂow meter set at 10 L/min. Additional nebulized epinephrine (5 mL) delivered in the same way could be administered with
blinded study solution at a maximum frequency of every hour, and additional treatment (eg, supplementary oxygen, hydration) could be given at the discretion of the treating physician. Patients were withdrawn from the study if oxygen saturation within 30 min after nebulization fell below 85% on room air or if clinical deterioration was deemed to warrant hospital admission. A patients could be discharged when the treating physician determined she or he did not need supplementary oxygen, was feeding adequately without intravenous ﬂuids, and had minimal or absent wheezing, crackles, and chest retractions, provided that oxygen saturation was $ 94% and the severity score was