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Comparing Different Ways of Delivering Humidity to Children With Croup

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00230841
Enrollment
129
Registered
2005-10-03
Start date
2001-09-30
Completion date
2004-04-30
Last updated
2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Croup

Keywords

croup, humidity therapy, pediatrics

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).

Interventions

DEVICEnebulized humidity

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
3 Months to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
steroid or epinephrine treatment at 60 minutes
discharge rate at 60 minutes
change in pulse, respiratory rate, and oxygen saturation at 60 minutes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026