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

ClinicalTrials.gov processed this record on October 20, 2014