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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier:
NCT01834820
First received: January 15, 2013
Last updated: July 4, 2015
Last verified: July 2015
  Purpose

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 Intervention Phase
Bronchiolitis
Drug: Epinephrine and Dexamethasone
Drug: Hypertonic Saline
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Change from baseline CBSS after three treatments in the first day [ Time Frame: First day of treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 120
Study Start Date: January 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 24 Months   (Child)
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
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.
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 
Study First Received: January 15, 2013
Last Updated: July 4, 2015
Health Authority: Mexico: Ministry of Health

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
Dexamethasone 21-phosphate
BB 1101
Epinephrine
Racepinephrine
Epinephryl borate
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

ClinicalTrials.gov processed this record on August 29, 2016