An interventional study of Outdoor cold air exposure in Croup, sponsored by Pediatric Clinical Research Platform. Completed. Open to participants aged 3 Months to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Pediatric Clinical Research Platform · Not applicable, Interventional, and Treatment
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.
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.
18 studies on the registry are indexed under Croup; 2 are open to participants now.
This study's enrollment of 118 is above the median of 86 across 12 interventional studies indexed under Croup.
Browse Croup studies →Pediatric Clinical Research Platform is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Indoor ambient air exposure (24-25°C or 75-77°C). Participants remained under observation at indoor ambient until 60 minutes from triage.
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.
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.
Time frame: at 30 minutes
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.
Time frame: at 60 minutes
Pulse oxymetry
Pulse oxymetry in %
Time frame: at 0 min, at 30 and at 60 minutes from enrolment at triage
Respiratory rate
Respiratory rate in breaths/min
Time frame: at 0 min, at 30 and at 60 minutes from enrolment at triage
Heart rate
Heart rate in beats/min
Time frame: 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
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
Hospitalisation rate
Rate of hospital admission for croup
Time frame: Within 7 days from the initial visit
Adverse events
Parental or patient perception of adverse events related to exposure to outdoor cold air.
Time frame: at 30 minutes from enrolment at triage
No study locations are listed for this record.
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: 6 month to 5 years after publication of results.
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.
Ran from Nov 2016 to primary completion in May 2021, 54 months.
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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