drugset / Trial / NCT01834820
Epinephrine, Dexamethasone, and Hypertonic Saline in Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety
RandomizedParallel-groupTriple-blindHealth-services research
Summary
In infancy, bronchiolitis is the most common acute infection of the lower respiratory Tract. The current treatment of bronchiolitis is controversial. Bronchodilators and corticosteroids are widely used but not routinely recommended. Hypertonic saline is currently the only drug recommended by the Spanish Association of Pediatrics in treatment guidelines. The purpose of this study is quantify whether epinephrine, dexamethasone, and hypertonic saline are effective to decrease the rate of hospital admissions at seven day, also verify adverse effects in patients submitted.
Timeline
- Start
- 2013-01
- Primary completion
- 2015-06
- Completion
- 2015-06
Publications
- Background Turner T, Wilkinson F, Harris C, Mazza D; Health for Kids Guideline Development Group. Evidence based guideline for the management of bronchiolitis. Aust Fam Physician. 2008 Jun;37(6 Spec No):6-13.
- Background American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
- Background Plint AC, Johnson DW, Patel H, Wiebe N, Correll R, Brant R, Mitton C, Gouin S, Bhatt M, Joubert G, Black KJ, Turner T, Whitehouse S, Klassen TP; Pediatric Emergency Research Canada (PERC). Epinephrine and dexamethasone in children with bronchiolitis. N Engl J Med. 2009 May 14;360(20):2079-89. doi: 10.1056/NEJMoa0900544.
- Background Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
- Background Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.
- Background Noyola DE, Rodriguez-Moreno G, Sanchez-Alvarado J, Martinez-Wagner R, Ochoa-Zavala JR. Viral etiology of lower respiratory tract infections in hospitalized children in Mexico. Pediatr Infect Dis J. 2004 Feb;23(2):118-23. doi: 10.1097/01.inf.0000110269.46528.a5.
- Background Intercollegiate S, Network G. Bronchiolitis in children. (SIGN Guideline No 91). 2006;(november).
- Background Nebot MS, Teruel GC, Cubells CL, Sabadell MD, Fernandez JP. [Acute bronchiolitis clinical practice guideline: recommendations for clinical practice]. An Pediatr (Barc). 2010 Oct;73(4):208.e1-10. doi: 10.1016/j.anpedi.2010.04.015. Epub 2010 Jul 14. Spanish.
- Background Acosta A et all. Diagnóstico y manejo en niños con Bronquiolitis en fase aguda, México: Secretaria de Salud. Catálogo maestro de Guías de práctica clínica: IMSS -032-08. 2010
- Background Hartling L, Bialy LM, Vandermeer B, Tjosvold L, Johnson DW, Plint AC, Klassen TP, Patel H, Fernandes RM. Epinephrine for bronchiolitis. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD003123. doi: 10.1002/14651858.CD003123.pub3.
- Background Patel H, Platt R, Lozano JM. WITHDRAWN: Glucocorticoids for acute viral bronchiolitis in infants and young children. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004878. doi: 10.1002/14651858.CD004878.pub2.
- Background Koehoorn M, Karr CJ, Demers PA, Lencar C, Tamburic L, Brauer M. Descriptive epidemiological features of bronchiolitis in a population-based cohort. Pediatrics. 2008 Dec;122(6):1196-203. doi: 10.1542/peds.2007-2231.
- Background Mansbach JM, Emond JA, Camargo CA Jr. Bronchiolitis in US emergency departments 1992 to 2000: epidemiology and practice variation. Pediatr Emerg Care. 2005 Apr;21(4):242-7. doi: 10.1097/01.pec.0000161469.19841.86.
- Background Jartti T, Jartti L, Ruuskanen O, Soderlund-Venermo M. New respiratory viral infections. Curr Opin Pulm Med. 2012 May;18(3):271-8. doi: 10.1097/MCP.0b013e328351f8d4.
- Background Corneli HM, Zorc JJ, Mahajan P, Shaw KN, Holubkov R, Reeves SD, Ruddy RM, Malik B, Nelson KA, Bregstein JS, Brown KM, Denenberg MN, Lillis KA, Cimpello LB, Tsung JW, Borgialli DA, Baskin MN, Teshome G, Goldstein MA, Monroe D, Dean JM, Kuppermann N; Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN). A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. N Engl J Med. 2007 Jul 26;357(4):331-9. doi: 10.1056/NEJMoa071255.
- Results Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
- Results Cantón SBF, Trujillo GG, Uribe RV. Principales causas de mortalidad infantil en México: tendencias recientes. Bol Med Hosp Infant Mex. 2012;69(2):144-8.
- Results Cincinnati Children's Hospital Medical Center. Evidence-based care guideline for management of first time episode bronchiolitis in infants less than 1 year of age.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 4 mg | Inhaled |
| Subject | Epinephrine | Other / unclassified | 3 ml | Inhaled |
| Subject | Hypertonic saline | Unknown | 4 ml | Inhaled |