Impact of Cold Air Exposure on Croup Symptoms

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

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.

Study Overview

• Status: Completed
• Conditions: Croup
• Intervention / Treatment: Other: Outdoor cold air exposure

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Westley croup score 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.	at 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Westley croup score 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.	at 60 minutes
Pulse oxymetry	Pulse oxymetry in %	at 0 min, at 30 and at 60 minutes from enrolment at triage
Respiratory rate	Respiratory rate in breaths/min	at 0 min, at 30 and at 60 minutes from enrolment at triage
Heart rate	Heart rate in beats/min	at 0 min, at 30 and at 60 minutes from enrolment at triage
Telephone Outpatient derived score	Anamnestic scoring tool to estimate croup severity, derived from the original Telephone Out Patient score	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
Hospitalisation rate	Rate of hospital admission for croup	Within 7 days from the initial visit
Adverse events	Parental or patient perception of adverse events related to exposure to outdoor cold air.	at 30 minutes from enrolment at triage

Collaborators and Investigators

• Sponsor: Pediatric Clinical Research Platform
• Investigators: Principal Investigator: Johan Siebert, MD, University Hospitals of Geneva

Publications and helpful links

General Publications

• Gates A, Gates M, Vandermeer B, Johnson C, Hartling L, Johnson DW, Klassen TP. Glucocorticoids for croup in children. Cochrane Database Syst Rev. 2018 Aug 22;8(8):CD001955. doi: 10.1002/14651858.CD001955.pub4.
• Hanna J, Brauer PR, Morse E, Berson E, Mehra S. Epidemiological analysis of croup in the emergency department using two national datasets. Int J Pediatr Otorhinolaryngol. 2019 Nov;126:109641. doi: 10.1016/j.ijporl.2019.109641. Epub 2019 Aug 13.
• Johnson DW. Croup. BMJ Clin Evid. 2014 Sep 29;2014:0321.
• Moore M, Little P. Humidified air inhalation for treating croup. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD002870. doi: 10.1002/14651858.CD002870.pub2.
• Bjornson CL, Williamson J, Johnson DW. Telephone Out Patient Score: The Derivation and Validation of a Telephone Follow-up Assessment Tool for Use in Clinical Research in Children With Croup. Pediatr Emerg Care. 2016 May;32(5):290-7. doi: 10.1097/PEC.0000000000000796.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Children; Pediatrics; Infant; Croup; Laryngitis; Laryngotracheitis; Laryngotracheobronchitis; Cold air
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngitis; Croup
• Other Study ID Numbers: 2016-00845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified Individual Participant Data will be available from the corresponding author upon reasonable request, recognizing that these data will only provide results for the current trial and not for future trials. Only deidentified/anonymized data will be shared.
• IPD Sharing Time Frame: 6 month to 5 years after publication of results.

IPD Sharing Access Criteria

Data will be made available from the corresponding author upon approval of a proposal and after a signed data access agreement.

Deidentified participant data will be made available to qualified external researchers who will use them according to their Institutional Review Board.

Data will be made available for a specified research purpose. The request proposal should include participation of a statistician.

• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No