Impact of Cold Air Exposure on Croup Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Croup

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label randomized controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exposition group

Outdoor cold air exposure (\<10°C or \<50°F) 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.

Group Type EXPERIMENTAL

Outdoor cold air exposure

Intervention Type OTHER

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.

Control group

Indoor ambient air exposure (24-25°C or 75-77°C). Participants remained under observation at indoor ambient until 60 minutes from triage.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Outdoor cold air exposure

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- children from 3 months to 10 years with clinical signs of croup and Westley croup score \> or =2

Exclusion Criteria

* Need for close monitoring
* Need for nebulized epinephrine
* History or physical examination suggesting any other diagnosis
* Chronic respiratory disease (except asthma)
* Underlying airway abnormalities
* Immunodeficiency
* Contraindication to steroids

Minimum Eligible Age

3 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes