Nebulized 5% Hypertonic Saline for the Treatment of Bronchiolitis - Full Text View

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:

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine

U.S. FDA Resources

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):

Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulized 5% or 3% hypertonic or 0.9% saline for treating acute bronchiolitis in infants. J Pediatr. 2010 Oct;157(4):630-4, 634.e1. Epub 2010 Jun 19.

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 May 22, 2013