Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department

NCT01660867 | Withdrawn Phase 4

• 1 other identifier: Bronchiolitis_1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Bronchiolitis

Keywords

hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone

Outcome Measures

Primary Outcomes (1)

• hospital admission within 7 days after the day of enrollment

  hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)

  within 7 days

Secondary Outcomes (5)

• RDAI score

  baseline, between nebulizer, 60min, 120min, 180min, 240min

• respiratory rate

  baseline, between nebulizer, 60min, 120min, 180min, 240min

• Heart rate

  baseline, between nebulizer, 60min, 120min, 180min, 240min

• Oxygen saturation

  baseline, between nebulizer, 60min, 120min, 180min, 240min

• unplanned revisit and admission rate after revisit

  in 7days

Study Arms (3)

0.9% saline + oral placebo

PLACEBO COMPARATOR

nebulized epinephrine + 0.9% saline + placebo =\> epinephrine + 0.9% saline

Drug: 0.9% saline + oral dexamethasone

3% saline + oral placebo

EXPERIMENTAL

nebulized epinephrine + 3% saline + placebo =\> nebulized epinephrine + 3% saline

Drug: 3% saline + oral placebo

0.9% saline + oral dexamethasone

ACTIVE COMPARATOR

nebulized epinephrine + 0.9% saline + dexamethasone =\> nebulized epinephrine + 0.9% saline

Drug: 0.9% saline + oral dexamethasone

Interventions

3% saline + oral placebo DRUG

nebulized epinephrine + 3% saline + placebo =\> nebulized epinephrine + 3% saline

3% saline + oral placebo

0.9% saline + oral dexamethasone DRUG

nebulized epinephrine + 0.9% saline + dexamethasone =\> nebulized epinephrine + 0.9% saline

0.9% saline + oral dexamethasone; 0.9% saline + oral placebo

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• mo \~ 24mo aged patients with bronchiolitis visit to emergency departments
• RDAI score 4-15

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

Sodium Chloride; Dexamethasone

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 9, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

KR (1)