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

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
xylometazoline HCL 0.05%
Epinephrine 1mg
Sponsored by
Schneider Children's Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Epinephrine, Nasal decongestant, RSV, xylometazoline, Bronchiolitis

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    Length of hospital stay

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 14, 2008
    Last Updated
    February 25, 2008
    Sponsor
    Schneider Children's Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00622817
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2002
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Schneider Children's Medical Center, Israel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis
    Keywords
    Epinephrine, Nasal decongestant, RSV, xylometazoline, Bronchiolitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    xylometazoline HCL 0.05%
    Other Intervention Name(s)
    xylometazoline HCL = Otrivin nasal drops
    Intervention Description
    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 Type
    Drug
    Intervention Name(s)
    Epinephrine 1mg
    Intervention Description
    Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
    Primary Outcome Measure Information:
    Title
    Length of hospital stay
    Time Frame
    Two years
    Secondary Outcome Measure Information:
    Title
    Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19907355
    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.
    Results Reference
    derived

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

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