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
  Purpose

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).


Condition Intervention
Bronchiolitis
Drug: xylometazoline HCL 0.05%
Drug: Epinephrine 1mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double Blinded Controled Study:Treatment With Adrenaline Inhalation Versus Nasal Decongestant Drops for Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Schneider Children's Medical Center, Israel:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to improve oxygen saturation, comparison of clinical scores , Needs of IV fluids [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: October 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
Drug: Epinephrine 1mg
Patients are treated with inhalation of epinephrine 1mg and nasal drops of 0.9% saline for each nostril every twelve hours.
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.
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

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

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Schneider Children's Medical Center, Israel

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Schneider Children's Medical Center, Israel, Sackler Medical Center, tel Aviv University
ClinicalTrials.gov Identifier: NCT00622817     History of Changes
Other Study ID Numbers: 2848
Study First Received: February 14, 2008
Last Updated: February 25, 2008
Health Authority: Israel: Ethics Commission

Keywords provided by Schneider Children's Medical Center, Israel:
Epinephrine
Nasal decongestant
RSV
xylometazoline
Bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephrine
Racepinephrine
Pseudoephedrine
Epinephryl borate
Ephedrine
Xylometazoline
Nasal Decongestants
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics

ClinicalTrials.gov processed this record on September 18, 2014