Epinephrine, Dexamethasone, and Hypertonic Saline in Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety

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ClinicalTrials.gov Identifier: NCT01834820

Recruitment Status : Completed

First Posted : April 18, 2013

Last Update Posted : July 8, 2015

Sponsor:

Information provided by (Responsible Party):

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Bronchiolitis	Drug: Epinephrine and Dexamethasone Drug: Hypertonic Saline Drug: Normal Saline	Phase 4

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	Pilot Study: Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety
Study Start Date :	January 2013
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Dexamethasone Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Epinephrine and Dexamethasone First day: One treatment of nebulized dexamethasone 4mg (1ml of dexamethasone 8mg/2ml) + 3ml NS, followed by two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) with interval 20 minutes. And one treatment of nebulized dexamethasone every 24h for three days.	Drug: Epinephrine and Dexamethasone
Experimental: Hypertonic Saline 3% 3 treatments of nebulized HS 3% 4ml in first day of treatment with interval 20 minutes And one treatment of nebulized HS 3% 4ml every 24 hours for 3 days	Drug: Hypertonic Saline
Active Comparator: Normal Saline 0.9% 3 treatments of nebulized Normal Saline 0.9% 4ml in first day of treatment with interval 20 minutes. And one treatment of nebulized Normal Saline 0.9% 4ml every 24 hours for 3 days	Drug: Normal Saline

Outcome Measures

Primary Outcome Measures :

Rate of hospital admissions at seven day in infants whit bronchiolitis. [ Time Frame: From date of randomization until the day seven of treatment ]
Tracking each patient until 7 days after treatment to verify hospitalization rate

Secondary Outcome Measures :

Number of participants with adverse events in each arm of treatment [ Time Frame: From date of randomization until the seven day of treatment ]

Other Outcome Measures:

Change from baseline CBSS after three treatments in the first day [ Time Frame: First day of treatment ]
Each patient on admission to the emergency department with a diagnosis of mild to moderate bronchiolitis were taken CBSS baseline, then at 20 minutes after completion three nebulized treatment in the first day.
Change from baseline heart rate after three treatments in the first day [ Time Frame: First day of treatment ]
Each patient on admission to the emergency department with a diagnosis of mild to moderate bronchiolitis were taken heart rate, then at 20 minutes after completion three nebulized treatment in the first day.
Change from baseline oxygen saturation after three treatments in the first day [ Time Frame: First day of treatment ]
Each patient on admission to the emergency department with a diagnosis of mild to moderate bronchiolitis were taken oxygen saturation, then at 20 minutes after completion three nebulized treatment in the first day.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Months to 24 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients under 2 years of age diagnosed with bronchiolitis
Be beneficiaries Marine
Outpatient
Severity of Bronchiolitis mild to moderate scale according to Wood-Downes

Exclusion Criteria:

Patients with a history of atopy
Patients with a history of asthma in infants
Patients with serious bacterial illness criteria
Patients with comorbidity

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834820

Locations


Mexico
Hospital General Naval de Alta Especialidad
México, Distrito Federal, Distrito Federal, Mexico, 04480

Sponsors and Collaborators

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators


Principal Investigator:	José Luis Rodríguez Cuevas, pediatrician

More Information

Publications of 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. Erratum in: Lancet. 2012 Oct 13;380(9850):1308.

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.

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.

Other Publications:

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.

American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93.

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.

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, Simões 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. Review.

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. Review.

Noyola DE, Rodríguez-Moreno G, Sánchez-Alvarado J, Martínez-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.

Intercollegiate S, Network G. Bronchiolitis in children. (SIGN Guideline No 91). 2006;(november).

Nebot MS, Teruel GC, Cubells CL, Sabadell MD, Fernández 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.

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

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;(6):CD003123. doi: 10.1002/14651858.CD003123.pub3. Review.

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. Review. Update in: Cochrane Database Syst Rev. 2010;(10):CD004878.

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.

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.

Jartti T, Jartti L, Ruuskanen O, Söderlund-Venermo M. New respiratory viral infections. Curr Opin Pulm Med. 2012 May;18(3):271-8. doi: 10.1097/MCP.0b013e328351f8d4. Review.

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. Erratum in: N Engl J Med. 2008 Oct 30;359(18):1972.. Majahan, Prashant [corrected to Mahajan, Prashant].


Responsible Party:	Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier:	NCT01834820 History of Changes
Other Study ID Numbers:	HGNAE-01
First Posted:	April 18, 2013 Key Record Dates
Last Update Posted:	July 8, 2015
Last Verified:	July 2015

Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:


Bronchiolitis Epinephrine Dexamethasone Hospitalization Hypertonic Saline

Additional relevant MeSH terms:


Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Dexamethasone acetate Dexamethasone Epinephrine Racepinephrine Epinephryl borate BB 1101 Anti-Inflammatory Agents Antiemetics	Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents

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