The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Drug: Epinephrine 1mg; Drug: xylometazoline HCL 0.05%

• Registration Number: NCT00622817
• Lead Sponsor: Schneider Children's Medical Center, Israel

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.

Study Timeline

• Status Verified: 2002-02
• Study Start: 2004-10
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Last Update Submitted: 2008-02-25
• Last Update Posted: 2008-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Epinephrine 1mg	Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
2	xylometazoline HCL 0.05%	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.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	Two years

Secondary Outcome Measures

Name	Time	Method
Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids	2 years