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Completed

NCT Number: NCT05668364

Impact of Cold Air Exposure on Croup Symptoms

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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Key information

Age range

3 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Outdoor cold air exposure

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.

Primary outcomes

  1. Westley croup score at 30 minutes

    Time frame: at 30 minutes

    The primary outcome is the proportion of patients showing an decrease of at least 2 points in their Westley croup score at 30 minutes from triage.

    The 5-item Westley croup score uses a 17 points ordinal scale to assess level of consciousness (5 points), cyanosis (5 points), stridor (2 points), air entry (2 points), and chest wall retractions (3 points). Mild croup is defined as a WCS < or = 2, moderate 3-5, severe 6-11, and impending respiratory failure or >12.

Secondary outcomes

  1. Westley croup score at 60 minutes

    Time frame: at 60 minutes

    The secondary outcome is the proportion of patients showing an decrease of at least 2 points in their Westley croup score at 60 minutes from triage.

    The 5-item Westley croup score uses a 17 points ordinal scale to assess level of consciousness (5 points), cyanosis (5 points), stridor (2 points), air entry (2 points), and chest wall retractions (3 points). Mild croup is defined as a WCS < or = 2, moderate 3-5, severe 6-11, and impending respiratory failure or >12.

  2. Pulse oxymetry

    Time frame: at 0 min, at 30 and at 60 minutes from enrolment at triage

    Pulse oxymetry in %

  3. Respiratory rate

    Time frame: at 0 min, at 30 and at 60 minutes from enrolment at triage

    Respiratory rate in breaths/min

  4. Heart rate

    Time frame: at 0 min, at 30 and at 60 minutes from enrolment at triage

    Heart rate in beats/min

  5. Telephone Outpatient derived score

    Time frame: at the time of leaving home for the pediatric emergency department visit; at 0 min on pediatric emergency department arrival (i.e., at triage); at day 7 from the initial visit

    Anamnestic scoring tool to estimate croup severity, derived from the original Telephone Out Patient score

  6. Hospitalisation rate

    Time frame: Within 7 days from the initial visit

    Rate of hospital admission for croup

  7. Adverse events

    Time frame: at 30 minutes from enrolment at triage

    Parental or patient perception of adverse events related to exposure to outdoor cold air.

Sponsors and collaborators

Lead sponsor

Pediatric Clinical Research Platform

Other

Registry information

Official study title

Outdoor Cold Air Exposure Versus Room Temperature for Croup Symptoms in Pediatric Emergency Departments: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2022
Registry last updated
Jan 11, 2023

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.

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