Overview

This trial is active, not recruiting.

Condition acute bronchiolitis
Treatments 3% saline + oral placebo, 0.9% saline + oral dexamethasone
Phase phase 4
Sponsor Seoul National University Hospital
Start date August 2012
End date August 2013
Trial size 336 participants
Trial identifier NCT01660867, Bronchiolitis_1

Summary

This is a prospective, randomized, controlled, double-blinded, clinical trial

Subject : 3mo ~ 24mo. aged infants with bronchiolitis

The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline
(Experimental)
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
3% saline + oral placebo
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
(Active Comparator)
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
0.9% saline + oral dexamethasone
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline

Primary Outcomes

Measure
hospital admission within 7 days after the day of enrollment
time frame: within 7 days

Secondary Outcomes

Measure
RDAI score
time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
respiratory rate
time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
Heart rate
time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
Oxygen saturation
time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min
unplanned revisit and admission rate after revisit
time frame: in 7days

Eligibility Criteria

Male or female participants from 3 months up to 24 months old.

Inclusion Criteria: - 3mo ~ 24mo aged patients with bronchiolitis visit to emergency departments - RDAI score 4-15 Exclusion Criteria: - < 3mo, > 24mo - infants who had received oral or inhaled corticosteroids during the preceding 2 weeks - infants with a previous episode of wheezing or a diagnosis of asthma - any chronic cardiopulmonary disease - immunodeficiency - infants needed intubation - infants with a previous history of apnea or intubation - infants with side effect of dexamethasone - infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation

Additional Information

Official title Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
Description Randomly assigned to one of three groups - Group I : nebulized epinephrine + 0.9% saline + placebo - Group II : nebulized epinephrine + 3% saline + placebo - Group III : nebulized epinephrine + 0.9% saline + dexamethasone Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone. The primary outcome is hospital admission within 7 days after the day of enrollment
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.