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

This study has been completed.
Sponsor:
Information provided by:
Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00622817
First received: February 14, 2008
Last updated: February 25, 2008
Last verified: February 2002

February 14, 2008
February 25, 2008
October 2004
March 2005   (final data collection date for primary outcome measure)
Length of hospital stay [ Time Frame: Two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622817 on ClinicalTrials.gov Archive Site
Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Bronchiolitis
  • 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.
    Other Name: xylometazoline HCL = Otrivin nasal drops
  • Drug: Epinephrine 1mg
    Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
  • Active Comparator: 1
    Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
    Intervention: Drug: Epinephrine 1mg
  • Experimental: 2
    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.
    Intervention: Drug: xylometazoline HCL 0.05%
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
March 2005
March 2005   (final data collection date for primary outcome measure)

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)
Both
1 Month to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00622817
2848
No
Schneider Children's Medical Center, Israel, Sackler Medical Center, tel Aviv University
Schneider Children's Medical Center, Israel
Not Provided
Not Provided
Schneider Children's Medical Center, Israel
February 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP