Clinical trial NCT05668364: Impact of Cold Air Exposure on Croup Symptoms
Official title: Outdoor Cold Air Exposure Versus Room Temperature for Croup Symptoms in Pediatric Emergency Departments: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Croup
Keywords: Croup
Laryngitis
Laryngotracheitis
Laryngotracheobronchitis
Pediatrics
Children
Infant
Cold air
Lead sponsor: Pediatric Clinical Research Platform
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 118
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label randomized controlled study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Westley croup score at 30 minutes
timeFrame: at 30 minutes
Secondary outcomes:
measure: Westley croup score at 60 minutes
timeFrame: at 60 minutes
measure: Pulse oxymetry
timeFrame: at 0 min, at 30 and at 60 minutes from enrolment at triage
measure: Respiratory rate
timeFrame: at 0 min, at 30 and at 60 minutes from enrolment at triage
measure: Heart rate
timeFrame: at 0 min, at 30 and at 60 minutes from enrolment at triage
measure: Telephone Outpatient derived score
timeFrame: 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
measure: Hospitalisation rate
timeFrame: Within 7 days from the initial visit
measure: Adverse events
timeFrame: at 30 minutes from enrolment at triage
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals of Geneva
name: Johan Siebert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Johnson DW. Croup. BMJ Clin Evid. 2014 Sep 29;2014:0321.
citation: 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.
citation: 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.