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Comparing Different Ways of Delivering Humidity to Children With Croup

T

The Hospital for Sick Children

Status and phase

Completed
Phase 2

Conditions

Croup

Treatments

Device: nebulized humidity

Study type

Interventional

Funder types

Other

Identifiers

NCT00230841
0020010158

Details and patient eligibility

About

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).

Sex

All

Ages

3 months to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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