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

Information source: Schneider Children's Medical Center, Israel
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchiolitis

Intervention: xylometazoline HCL 0.05% (Drug); Epinephrine 1mg (Drug)

Phase: N/A

Status: Completed

Sponsored by: Schneider Children's Medical Center, Israel

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).

Clinical Details

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

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

Primary outcome: Length of hospital stay

Secondary outcome: Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids

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.

Eligibility

Minimum age: 1 Month. Maximum age: 12 Months. Gender(s): Both.

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)

Locations and Contacts

Additional Information

Starting date: October 2004
Last updated: February 25, 2008

Page last updated: August 20, 2015

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