The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis
1 other identifier
interventional
65
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2004
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedFebruary 26, 2008
February 1, 2002
5 months
February 14, 2008
February 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of hospital stay
Two years
Secondary Outcomes (1)
Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids
2 years
Study Arms (2)
1
ACTIVE COMPARATORPatients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
2
EXPERIMENTALReceive 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.
Interventions
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.
Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
Eligibility Criteria
You may qualify if:
- Full term previously healthy Infants
- Ages 1-12 months
- After informed consent was signed with clinical presentation of mild to moderate bronchiolitis
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 19907355DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 25, 2008
Study Start
October 1, 2004
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
February 26, 2008
Record last verified: 2002-02