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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00622817

Enrollment

Registered

2008-02-25

Start date

2004-10-31

Completion date

2005-03-31

Last updated

2008-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

Epinephrine, Nasal decongestant, RSV, xylometazoline, Bronchiolitis

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.

Interventions

DRUGxylometazoline 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.

DRUGEpinephrine 1mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Months to 12 Months

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Length of hospital stay	Two years

Secondary

Measure	Time frame
Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids	2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026