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Nebulized 5% Hypertonic Saline for the Treatment of Bronchiolitis

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ClinicalTrials.gov Identifier: NCT01016249
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : November 19, 2009
Sponsor:
Information provided by:
Hamad Medical Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Bronchiolitis Drug: Treatment 1. (5% Hypertonic saline + Epinephrine) Drug: Treatment 3. (3% Hypertonic saline + Epinephrine) Drug: Treatment 2. (Normal saline + Epinephrine) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized 5% Hypertonic Saline for Infirmary Treatment of Acute Infant Bronchiolitis: A Randomized Trial
Study Start Date : April 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Mean pre-nebulization bronchiolitis severity score for each treatment group at 48 hours [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

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
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents