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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Jin Hee Lee, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jin Hee Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01660867
First received: August 3, 2012
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Acute Bronchiolitis Drug: 3% saline + oral placebo Drug: 0.9% saline + oral dexamethasone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Jin Hee Lee, Seoul National University Hospital:

Primary Outcome Measures:
  • hospital admission within 7 days after the day of enrollment [ Time Frame: within 7 days ]
    hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)


Secondary Outcome Measures:
  • RDAI score [ Time Frame: baseline, between nebulizer, 60min, 120min, 180min, 240min ]
    RDAI score

  • respiratory rate [ Time Frame: baseline, between nebulizer, 60min, 120min, 180min, 240min ]
    respiratory rate

  • Heart rate [ Time Frame: baseline, between nebulizer, 60min, 120min, 180min, 240min ]
    Heart rate

  • Oxygen saturation [ Time Frame: baseline, between nebulizer, 60min, 120min, 180min, 240min ]
    Oxygen saturation

  • unplanned revisit and admission rate after revisit [ Time Frame: in 7days ]
    unplanned revisit admission rate after revisit


Estimated Enrollment: 336
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0.9% saline + oral placebo
nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline
Experimental: 3% saline + oral placebo
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
Drug: 3% saline + oral placebo
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
Active Comparator: 0.9% saline + oral dexamethasone
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
Drug: 0.9% saline + oral dexamethasone
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline

Detailed 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

  Eligibility

Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660867

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Jin Hee Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01660867     History of Changes
Other Study ID Numbers: Bronchiolitis_1
Study First Received: August 3, 2012
Last Updated: August 8, 2012

Keywords provided by Jin Hee Lee, Seoul National University Hospital:
hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone

Additional relevant MeSH terms:
Emergencies
Bronchiolitis
Disease Attributes
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Dexamethasone acetate
Dexamethasone
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

ClinicalTrials.gov processed this record on August 18, 2017