Nebulized 5% Hypertonic Saline for the Treatment of Bronchiolitis

This study has been completed.
Sponsor:
Information provided by:
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01016249
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

The investigators reasoned that a hypertonic saline concentration higher than 3% could be safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and preventing the need for hospitalization in some instances.


Condition Intervention Phase
Bronchiolitis
Drug: Treatment 1. (5% Hypertonic saline + Epinephrine)
Drug: Treatment 3. (3% Hypertonic saline + Epinephrine)
Drug: Treatment 2. (Normal saline + Epinephrine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized 5% Hypertonic Saline for Infirmary Treatment of Acute Infant Bronchiolitis: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The treatments' severity scores at 24 hours and trend over time to 72 hours, 2 hours-post-nebulization severity scores trending over time, as well as safety measures [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 187
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment 1. 5% Saline + Epinephrine
Nebulization with 4ml of 5% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.
Drug: Treatment 1. (5% Hypertonic saline + Epinephrine)
Nebulization of 4ml 5% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.
Other Name: 5% Hypertonic saline
Treatment 3. 3% Saline + Epinephrine
Nebulization with 4ml of 3% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.
Drug: Treatment 3. (3% Hypertonic saline + Epinephrine)
Nebulization of 4ml 3% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.
Other Name: 3% Hypertonic saline
Treatment 2 . 0.9% Saline + Epinephrine
Nebulization with 4ml of 0.9% saline mixed with 1.5 ml of epinephrine every 4 hours thereafter until ready for discharge. Immediately before nebulization, just after, and 2 hours after, the following measurements were collected for each patients: bronchiolitis severity score, oxygen saturation on room air, and heart rate.
Drug: Treatment 2. (Normal saline + Epinephrine)
Nebulization of 4ml 0.9% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.
Other Name: Normal saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants aged ≤ 18 months presenting to the unit for the treatment of moderate-severe viral bronchiolitis were eligible for the study.
  • Moderate-severe bronchiolitis required having a prodromal history consistent with viral upper respiratory tract infection followed by wheezing and/or crackles on auscultation and a Wang bronchiolitis severity score of ≥ 4 on presentation.

Exclusion Criteria:

Patients were excluded from the study if they had one or more of the following characteristics:

  • Born preterm ≤ 34 weeks gestation,
  • Previous history of wheezing,
  • Steroid use within 48 hours of presentation,
  • Obtundation and progressive respiratory failure requiring ICU admission,
  • History of apnea with in 24 hours before presentation,
  • Oxygen saturation ≤ 85% on room air at the time of recruitment,
  • History of a diagnosis of chronic lung disease,
  • Congenital heart disease, or
  • Immunodeficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016249

Locations
Qatar
Pediatric Emergency Center, Al-Saad
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Principal Investigator: Khalid M. Al-Ansari, FRCPC,FAAP Hamad Medical Corporation, Weill Cornell Medical College
  More Information

No publications provided by Hamad Medical Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Khalid Al Ansari, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01016249     History of Changes
Other Study ID Numbers: #7055
Study First Received: November 18, 2009
Last Updated: November 18, 2009
Health Authority: Qatar: Hamad Medical Corporation

Keywords provided by Hamad Medical Corporation:
Bronchiolitis, Viral
An acute inflammation of the upper RESPIRATORY TRACT

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 22, 2014