Impact of Cold Air Exposure on Croup Symptoms
Condition: Croup
MeSH terms: Laryngitis; Croup
Study type: Interventional

Summary: 
      The goal of the present randomised controlled clinical trial is to compare the efficacy of a
      30-minute exposition to cold, atmospheric, outdoor air on the severity of croup symptoms with
      exposition to indoor room air in children with mild to moderate croup receiving a single dose
      of dexamethasone during winter croup outbreaks.
    

Detailed description: 
      Croup is a viral laryngitis that represents the most common cause of acute upper airway
      obstruction in children. It is therefore a frequent reason for emergency department visits.
      The benefit of dexamethasone on croup symptoms is well established with an onset of action of
      at least 30 minutes. Various non-pharmacological measures, including exposition to cold air,
      are also thought to be effective in reducing the severity of symptoms, although this has not
      been demonstrated yet in the current scientific literature. The aim of the present study is
      to evaluate the efficacy of exposition to cold air on the symptoms of croup in children.

      The investigators designed a prospective, open-label, single centre randomised controlled
      trial to evaluate the effect of exposition to cold air on the symptoms of croup in children.

      The study was performed during autumn and winter croup outbreaks when outdoor air temperature
      was <10°C (<50°F). Participants were infants and children aged 3 months to 10 years
      presenting to the pediatric emergency department of our institution. Inclusion criteria were
      patients presenting with mild to moderate croup symptoms with Westley croup scores > or=2 (to
      permit a clinically relevant reduction in the Westley croup score of at least 2 points from
      baseline at 30 minutes), diagnosed by a triage nurse and confirmed by a senior attending
      pediatric emergency physician. Exclusion criteria were history or physical examination
      suggesting any other diagnosis, severe croup requiring immediate nebulised epinephrine,
      chronic respiratory disease (except asthma), underlying airway abnormalities,
      immunodeficiency; and contraindication to steroids. According to the recommended standards of
      care, all children with croup were administered a standard 0·6 mg/kg/dose oral dexamethasone
      at triage.

      Participants were randomly allocated either to the outdoor cold air exposition group or to
      the indoor group allocation using a single, constant 1:1 allocation ratio. Demographic data,
      previous exposition to cold air before presentation at pediatric emergency department, as
      well as vital signs and Westley croup score on arrival, and after 30 and 60 minutes, were
      recorded. Parents were reached by phone 7 days after the initial visit to assess the child's
      clinical outcome and the final diagnosis, as well as the need for further consultation or
      hospitalization in the meantime.
    

Intervention name(s): Outdoor cold air exposure
Intervention type(s): Other
Intervention description(s): Exposure to outdoor cold air (<10°C or <50°F, intervention group) for 30 minutes. On completion of the intervention, participants remained under observation at indoor ambient air from 30 minutes to 60 minutes from the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label randomized controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Croup; Laryngitis; Laryngotracheitis; Laryngotracheobronchitis; Pediatrics; Children; Infant; Cold air