NCT00114478

Brief Summary

The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC). Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat this disease but nobody knows which one, if any, works the best. Two of the most commonly used drugs are albuterol and epinephrine. These are both drugs given during breathing treatments with oxygen and a mask. We are doing this study to see which of these drugs works better or if they are both equally good. The study works as follows: after the consent process the baby gets three treatments.

  • Nebulizer 1 (Treatment)
  • Treatment + 30 minutes (approximately) Nebulizer 2
  • Treatment + 60 minutes (approximately) Nebulizer 3
  • Treatment + 120 minutes (approximately) The baby will be reevaluated and either discharged home or revert to standard therapy. If the baby is discharged directly from the emergency department (E.D.), we will call you in three days time to see how he/she is doing.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

First QC Date

June 15, 2005

Last Update Submit

January 23, 2008

Conditions

Bronchiolitis

Keywords

Bronchiolitisdispositionpediatricepinephrinealbuterol

Outcome Measures

Primary Outcomes (1)

  • Successful hospital discharge at three days

Secondary Outcomes (2)

  • Improvement in severity of disease score

  • Improvement in respiratory status

Interventions

EpinephrineDRUG
albuterol (salbutamol)DRUG

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A clinical diagnosis of bronchiolitis

You may not qualify if:

  • Age greater than 18 months
  • Disease too mild to warrant any treatment
  • Emergent intubation on arrival at the ED
  • Participation within another study within 30 days
  • Refusal of informed parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kern Medical Center

Bakersfield, California, 93312, United States

Location

Related Publications (2)

  • Walsh P, Rothenberg SJ, O'Doherty S, Hoey H, Healy R. A validated clinical model to predict the need for admission and length of stay in children with acute bronchiolitis. Eur J Emerg Med. 2004 Oct;11(5):265-72. doi: 10.1097/00063110-200410000-00005.

    PMID: 15359199BACKGROUND

  • Walsh P, Caldwell J, McQuillan KK, Friese S, Robbins D, Rothenberg SJ. Comparison of nebulized epinephrine to albuterol in bronchiolitis. Acad Emerg Med. 2008 Apr;15(4):305-13. doi: 10.1111/j.1553-2712.2008.00064.x.

    PMID: 18370982DERIVED

Related Links

MeSH Terms

Conditions

Bronchiolitis

Interventions

EpinephrineAlbuterol

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenethylaminesEthylamines

Study Officials

  • Paul Walsh, Paul Walsh, MD MSc(peds)

    Kern Medical Center, David Geffen School of Medicine, UCLA

    PRINCIPAL INVESTIGATOR

  • Paul Walsh

    Research Director, Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2005

First Posted

June 16, 2005

Study Start

November 1, 2003

Study Completion

May 1, 2006

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

US(1)