Clinical trial NCT00622817: The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
Official title: Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Epinephrine
Nasal decongestant
RSV
xylometazoline
Bronchiolitis
Lead sponsor: Schneider Children's Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Length of hospital stay
timeFrame: Two years
Secondary outcomes:
measure: Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: 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.