The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
xylometazoline HCL 0.05%
Epinephrine 1mg
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Epinephrine, Nasal decongestant, RSV, xylometazoline, Bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- Full term previously healthy Infants
- Ages 1-12 months
- After informed consent was signed with clinical presentation of mild to moderate bronchiolitis
Exclusion Criteria:
- Prematurity, congenital lung or cardiac disease
- Infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score >7 with a range scale 0-10)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.
Outcomes
Primary Outcome Measures
Length of hospital stay
Secondary Outcome Measures
Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids
Full Information
NCT ID
NCT00622817
First Posted
February 14, 2008
Last Updated
February 25, 2008
Sponsor
Schneider Children's Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00622817
Brief Title
The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
Official Title
Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2002
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Schneider Children's Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis.
The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis.
Signed informed consent was obtained from a parent of each child. And the human ethics committee of our hospital approved the study according to the principles of the Declaration of Helsinki.(Approved - 2002)
Patients:
65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider Children's Medical Center because of bronchiolitis during winter in two consecutive years 2004-2005.
The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after informed consent was signed with clinical presentation of mild to moderate bronchiolitis according to a clinical score .Exclusion criteria were as follows: prematurity, congenital lung or cardiac disease, infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score>7 with a range scale 0-10).
Detailed Description
All eligible patients were randomly assigned to one of two groups: Group 1 (control) received inhalation of epinephrine 1mg, in 2cc of 0.9% saline solution four times a day, and nasal drops of 0.9% saline for each nostril every twelve hours. Group 2 - the study group received four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL to each nostril twice a day. This treatment continued until the patient was ready for discharge.
Patients were examined and evaluated at the study entry and were re-evaluated every 10-12 hours. Length of hospital stay,time to improve Oxygen saturation, time to the need of IV fluid and clinical score between the two groups of treatment were compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Epinephrine, Nasal decongestant, RSV, xylometazoline, Bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
Arm Title
2
Arm Type
Experimental
Arm Description
Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.
Intervention Type
Drug
Intervention Name(s)
xylometazoline HCL 0.05%
Other Intervention Name(s)
xylometazoline HCL = Otrivin nasal drops
Intervention Description
Receive four inhalation of 0.9% saline four times a day and one nasal drop of xylometazoline HCL 0.05% to each nostril twice a day.
Intervention Type
Drug
Intervention Name(s)
Epinephrine 1mg
Intervention Description
Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
Primary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Full term previously healthy Infants
Ages 1-12 months
After informed consent was signed with clinical presentation of mild to moderate bronchiolitis
Exclusion Criteria:
Prematurity, congenital lung or cardiac disease
Infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score >7 with a range scale 0-10)
12. IPD Sharing Statement
Citations:
PubMed Identifier
19907355
Citation
Livni G, Rachmel A, Marom D, Yaari A, Tirosh N, Ashkenazi S. A randomized, double-blind study examining the comparative efficacies and safety of inhaled epinephrine and nasal decongestant in hospitalized infants with acute bronchiolitis. Pediatr Infect Dis J. 2010 Jan;29(1):71-3. doi: 10.1097/INF.0b013e3181b0602e.
Results Reference
derived
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The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
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