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Clinical Trials/NCT01834820
NCT01834820CompletedPhase 4

Pilot Study: Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety

Hospital General Naval de Alta Especialidad - Escuela Medico Naval1 site in 1 country120 target enrollmentStarted: January 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Rate of hospital admissions at seven day in infants whit bronchiolitis.

Study Overview

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.

Detailed Description

Infections remain the leading cause of death globally, in 2010 from 7.6 million deaths in children under 5 years, 64% is attributed to an infectious cause, acute lower respiratory tract include 14.1% of all deaths, representing the leading cause of global mortality in children. In Mexico in children under 15 years the leading cause of death are conditions originating in the perinatal period, congenital malformations deformities and chromosomal abnormalities and third lower airway infections.

Bronchiolitis being the leading cause of lower respiratory tract infection in infants, with a global load elevated, represented by a hospitalization rate of 3% of the total population of children under one year. Estimated that only in the United States of America, the annual cost of hospitalizations of patients under one year with bronchiolitis exceeds $ 700 million / year. Unfortunately, there is evidence that hospital admission rates have increased almost twice in the last 10-15 years in the United States and Canada, and it occurs most impact in developing countries, where befall 99% of deaths related to Respiratory Syncytial Virus (RSV), the leading cause of infection of lower airways.

The etiology of the disease is attributed by 50 to 80% of all cases the RSV worldwide, has been reported in Mexico RSV as a cause of just over 80% of infections lower airway requiring hospitalization.

Given such alarming morbidity figures, note that the mortality from this disease is low, representing less than 400 deaths annually, perhaps explained by the wide clinical spectrum that presents.

Currently no management guide recommends specific treatment for bronchiolitis, in particular, it is necessary to mention the national clinical practice guideline, which emphasizes that there is no consensus on proper drug treatment for this disease.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
2 Months to 24 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Epinephrine and Dexamethasone (Drug)

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

Intervention: Hypertonic Saline (Drug)

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

Intervention: Normal Saline (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Number of participants with adverse events in each arm of treatment(From date of randomization until the seven day of treatment)

Investigators

Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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