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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

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 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


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



Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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.

  2. 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.

  3. 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.



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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

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

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

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