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

Bronchiolitis Clinical Trial

Official title:

Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622817
• Other study ID #: 2848
• Status: Completed
• Phase: N/A
• First received: February 14, 2008
• Last updated: February 25, 2008
• Start date: October 2004
• Est. completion date: March 2005

Study information

• Verified date: February 2002
• Source: Schneider Children's Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 12 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• 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.
• Epinephrine 1mg
Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Schneider Children's Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay		Two years	No
Secondary	Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids		2 years	Yes