Croup Clinical Trial - Impact of Cold Air Exposure on Croup Symptoms

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05668364
Study type	Interventional
Source	Pediatric Clinical Research Platform
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2016
Completion date	May 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT01748162` - Management of Recurrent Croup	Phase 3
Completed	`NCT00230841` - Comparing Different Ways of Delivering Humidity to Children With Croup	Phase 2
Terminated	`NCT00147849` - A Cluster Controlled Trial Comparing Three Methods of Disseminating Practice Guidelines for Children With Croup	N/A
Terminated	`NCT03705273` - Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup	Phase 4
Completed	`NCT01042145` - Community Care for Croup (RCT)	Phase 4
Completed	`NCT00368823` - A Trial of Point of Care Information in Ambulatory Pediatrics	Phase 3
Not yet recruiting	`NCT06272383` - Croup Dosing Study	Phase 1
Completed	`NCT03392363` - Diagnosing Respiratory Disease in Children Using Cough Sounds 2
Recruiting	`NCT01664507` - The Effect and Safety of Low Dose Nebulized Epinephrine in Croup	Phase 4
Completed	`NCT06156436` - A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department
Not yet recruiting	`NCT04168554` - Telemedicine in the Generals Practitioners Office
Completed	`NCT02973282` - Diagnosing Respiratory Disease in Children Using Cough Sounds	N/A
Terminated	`NCT00938353` - Efficacy of Nebulized Beclomethasone Dipropionate (BDP) in the Treatment of Moderate Croup	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.