Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
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Purpose
Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rsv Bronchiolitis |
Drug: nebulized epinephrine and nebulized albuterol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study |
- respiratory clinical score
- computerized quantification of wheezing and crackles
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2000 |
| Estimated Study Completion Date: | May 2001 |
Inpatient Infants younger than 2 years of age with first episode of RSV bronchiolitis will be randomly assigned to treatment with nebulized epinephrine (1 mg diluted with 3 ml of 0.9% saline) or nebulized albuterol (2.5 mg diluted with 3.5 ml of 0.9% saline). Both solutions will be provided in identical containers.
Clinical assessment and clinical score will be done before treatment, 10 and 30 minutes after treatment. The following parameters were recorded at each time point, wheezing, respiratory distress, O2 saturation, respiratory rate and heart rate. Computerized lung sounds as well, will be recorded before treatment, 10 and 30 minutes after treatment via 4 contact sensors attached to the chest.
Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Under one year of age
- first episode of wheezing and dyspnea
- RSV antigen detected by ELISA
- parents signed informed consent.
Exclusion Criteria:
- infants with chronic lung disease
- cardiac disease
- other chronic conditions.
Contacts and Locations| Israel | |
| Pediatric Ward, Rambam Medical Centre | |
| Haifa, Israel, 31096 | |
| Principal Investigator: | LEA BENTUR, MD | Rambam medical centre, pediatric pulmonary unit, HAIFA |
More Information
No publications provided by Rambam Health Care Campus
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00361452 History of Changes |
| Other Study ID Numbers: | epinephrine_albuterol_rsv.ctil |
| Study First Received: | August 6, 2006 |
| Last Updated: | August 6, 2006 |
| Health Authority: | Israel: Ethics Commission |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Epinephrine Albuterol Epinephryl borate 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 Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on June 18, 2013