NCT00230841

Brief Summary

Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. This study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2001

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

First QC Date

September 29, 2005

Last Update Submit

July 31, 2013

Conditions

Croup

Keywords

crouphumidity therapypediatrics

Outcome Measures

Primary Outcomes (1)

  • changes in the croup score from baseline to 30 and 60 minutes

Secondary Outcomes (3)

  • steroid or epinephrine treatment at 60 minutes

  • discharge rate at 60 minutes

  • change in pulse, respiratory rate, and oxygen saturation at 60 minutes

Interventions

nebulized humidityDEVICE

Eligibility Criteria

Age3 Months - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged 3 months - 10 years
  • croup score greater than or equal to 2 after a 30 minute waiting period

You may not qualify if:

  • Symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation
  • symptoms or signs of alternative causes of stridor
  • inability of caregivers to understand or speak English and/or sign for informed consent
  • history of chronic pulmonary disease except for asthma, or co-existent systemic disease
  • previous history of intubation
  • duration of present illness \>1 week
  • systemic or inhaled glucocorticoids in previous 48 hours
  • epinephrine in previous 4 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Scolnik D, Coates AL, Stephens D, Da Silva Z, Lavine E, Schuh S. Controlled delivery of high vs low humidity vs mist therapy for croup in emergency departments: a randomized controlled trial. JAMA. 2006 Mar 15;295(11):1274-80. doi: 10.1001/jama.295.11.1274.

    PMID: 16537737RESULT

MeSH Terms

Conditions

Croup

Condition Hierarchy (Ancestors)

LaryngitisLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Dennis Scolnik, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Start

September 1, 2001

Study Completion

April 1, 2004

Last Updated

August 2, 2013

Record last verified: 2013-07

Locations

CA(1)