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

NCT01834820 | Completed Phase 4 DMC

• 1 other identifier: HGNAE-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; Epinephrine; Dexamethasone; Hospitalization; Hypertonic Saline

Outcome Measures

Primary Outcomes (1)

• Rate of hospital admissions at seven day in infants whit bronchiolitis.

  Tracking each patient until 7 days after treatment to verify hospitalization rate

  From date of randomization until the day seven of treatment

Secondary Outcomes (1)

• Number of participants with adverse events in each arm of treatment

  From date of randomization until the seven day of treatment

Other Outcomes (3)

• Change from baseline CBSS after three treatments in the first day

  First day of treatment

• Change from baseline heart rate after three treatments in the first day

  First day of treatment

• Change from baseline oxygen saturation after three treatments in the first day

  First day of treatment

Study Arms (3)

Epinephrine and Dexamethasone

EXPERIMENTAL

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

Hypertonic Saline 3%

EXPERIMENTAL

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

Normal Saline 0.9%

ACTIVE COMPARATOR

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

Interventions

Epinephrine and Dexamethasone DRUG

Epinephrine and Dexamethasone

Hypertonic Saline DRUG

Hypertonic Saline 3%

Normal Saline DRUG

Normal Saline 0.9%

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital General Naval de Alta Especialidad - Escuela Medico Naval: lead

Study Sites (1)

Hospital General Naval de Alta Especialidad

Mexico City, Mexico City, 04480, Mexico

Location

Related Publications (18)

• 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.

  PMID: 19142264 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.

  PMID: 17015575 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.

  PMID: 19439742 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.

  PMID: 20399493 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.

  PMID: 20100768 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.

  PMID: 14872176 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.

  PMID: 20634158 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;(6):CD003123. doi: 10.1002/14651858.CD003123.pub3.

  PMID: 21678340 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.

  PMID: 18254063 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.

  PMID: 19047234 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.

  PMID: 15824683 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.

  PMID: 22366993 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.

  PMID: 17652648 BACKGROUND

• 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.

  PMID: 22579125 RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Bronchiolitis

Interventions

Epinephrine; Dexamethasone; Saline Solution, Hypertonic; Saline Solution

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Study Officials

• José Luis Rodríguez Cuevas, pediatrician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: April 18, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

ME (1)