The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis
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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 |
- Length of hospital stay [ Time Frame: Two years ] [ Designated as safety issue: No ]
- 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 |
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 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 Pseudoephedrine Phenylephrine Oxymetazoline Epinephryl borate Ephedrine Xylometazoline Nasal Decongestants |
Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists |
ClinicalTrials.gov processed this record on May 22, 2013