Skip to main content
OpenTrials
Completed

NCT Number: NCT00230841

Comparing Different Ways of Delivering Humidity to Children With Croup

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Croup Laryngeal Diseases Laryngitis Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

3 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebulized humidity

Device

Primary outcomes

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

Secondary outcomes

  1. steroid or epinephrine treatment at 60 minutes

  2. discharge rate at 60 minutes

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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Oct 3, 2005
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.