Comparing Different Ways of Delivering Humidity to Children With Croup

Croup Clinical Trial

Official title:

Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230841
• Other study ID #: 0020010158
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2005
• Last updated: July 31, 2013
• Start date: September 2001
• Est. completion date: April 2004

Study information

• Verified date: July 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 10 Years

Eligibility

Inclusion Criteria:

• children aged 3 months - 10 years

• croup score greater than or equal to 2 after a 30 minute waiting period

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Croup

Intervention

Device:
• nebulized humidity

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the croup score from baseline to 30 and 60 minutes
Secondary	steroid or epinephrine treatment at 60 minutes
Secondary	discharge rate at 60 minutes
Secondary	change in pulse, respiratory rate, and oxygen saturation at 60 minutes