NCT00361452

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2000

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
Last Updated

August 8, 2006

Status Verified

November 1, 2000

First QC Date

August 6, 2006

Last Update Submit

August 6, 2006

Conditions

Rsv Bronchiolitis

Outcome Measures

Primary Outcomes (2)

  • respiratory clinical score

  • computerized quantification of wheezing and crackles

Interventions

nebulized epinephrine and nebulized albuterolDRUG

Eligibility Criteria

Age0 Years - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Under one year of age
  • first episode of wheezing and dyspnea
  • RSV antigen detected by ELISA
  • parents signed informed consent.

You may not qualify if:

  • infants with chronic lung disease
  • cardiac disease
  • other chronic conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Ward, Rambam Medical Centre

Haifa, 31096, Israel

Location

Related Publications (1)

  • Beck R, Elias N, Shoval S, Tov N, Talmon G, Godfrey S, Bentur L. Computerized acoustic assessment of treatment efficacy of nebulized epinephrine and albuterol in RSV bronchiolitis. BMC Pediatr. 2007 Jun 2;7:22. doi: 10.1186/1471-2431-7-22.

    PMID: 17543129DERIVED

Study Officials

  • LEA BENTUR, MD

    Rambam medical centre, pediatric pulmonary unit, HAIFA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2006

First Posted

August 8, 2006

Study Start

December 1, 2000

Study Completion

May 1, 2001

Last Updated

August 8, 2006

Record last verified: 2000-11

Locations

IL(1)