CroupNCT05668364
Impact of Cold Air Exposure on Croup Symptoms
A study testing Outdoor cold air exposure in people with Croup, run by Pediatric Clinical Research Platform.
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… Read more about this study
- Who is it for?
- Ages 3 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Croup
- What is being tested?
- Outdoor cold air exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children from 3 months to 10 years with clinical signs of croup and Westley croup score > or =2
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Croup
- Being tested
- Outdoor cold air exposure
- Keywords
- Croup, Laryngitis, Laryngotracheitis, Laryngotracheobronchitis, Pediatrics, Children, Infant, Cold air
- Medical subject headings
- Croup, Laryngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor cold air exposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposition group | Experimental | 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. Receives: Other: Outdoor cold air exposure |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 30 minutes
Secondary outcomes (7)
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.
Measured: at 60 minutes
Pulse oxymetry
Pulse oxymetry in %
Measured: at 0 min, at 30 and at 60 minutes from enrolment at triage
Respiratory rate
Respiratory rate in breaths/min
Measured: at 0 min, at 30 and at 60 minutes from enrolment at triage
Heart rate
Heart rate in beats/min
Measured: 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
Measured: 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
Measured: Within 7 days from the initial visit
Adverse events
Parental or patient perception of adverse events related to exposure to outdoor cold air.
Measured: at 30 minutes from enrolment at triage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start1 Nov 2016
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CroupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label randomized controlled study
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Siebert, MD, Pediatric Clinical Research Platform
- Investigators
- Johan Siebert, MD, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668364
- Sponsor's protocol ID
- 2016-00845
- Other IDs
- 2016
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 30133690Hanna 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.
PubMed 31442871Johnson DW. Croup. BMJ Clin Evid. 2014 Sep 29;2014:0321.
PubMed 25263284Moore M, Little P. Humidified air inhalation for treating croup. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD002870. doi: 10.1002/14651858.CD002870.pub2.
PubMed 16855994Bjornson 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.
PubMed 27139290Siebert JN, Salomon C, Taddeo I, Gervaix A, Combescure C, Lacroix L. Outdoor Cold Air Versus Room Temperature Exposure for Croup Symptoms: A Randomized Controlled Trial. Pediatrics. 2023 Sep 1;152(3):e2023061365. doi: 10.1542/peds.2023-061365.
PubMed 37525974
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outdoor Cold Air Exposure Versus Room Temperature for Croup Symptoms in Pediatric Emergency Departments: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05668364
- Acronym / sponsor ID
- 2016-00845
- Conditions
- Croup
- Keywords
- Croup, Laryngitis, Laryngotracheitis, Laryngotracheobronchitis, Pediatrics, Children, Infant, Cold air
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Exposition group | Experimental | Other: Outdoor cold air exposureOutdoor 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. |
| Control group | No intervention | –Indoor ambient air exposure (24-25°C or 75-77°C). Participants remained under observation at indoor ambient until 60 minutes from triage. |
Who may qualify
- Ages
- 3 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children from 3 months to 10 years with clinical signs of croup and Westley croup score > or =2
Key exclusion criteria (7 listed)
- Need for close monitoring
- Need for nebulized epinephrine
- History or physical examination suggesting any other diagnosis
- Chronic respiratory disease (except asthma)
- Underlying airway abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outdoor cold air exposureExposure 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. | Other | Exposition group |
Primary outcome
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.
7 secondary outcomes
Westley croup score at 60 minutes
Time frame: at 60 minutes
Pulse oxymetry
Time frame: at 0 min, at 30 and at 60 minutes from enrolment at triage
Respiratory rate
Time frame: at 0 min, at 30 and at 60 minutes from enrolment at triage
Heart rate
Time frame: at 0 min, at 30 and at 60 minutes from enrolment at triage
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
Hospitalisation rate
Time frame: Within 7 days from the initial visit
Adverse events
Time frame: at 30 minutes from enrolment at triage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Background: PubMed 30133690Gates 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.
- Results publication: PubMed 31442871Hanna 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.
- Results publication: PubMed 25263284Johnson DW. Croup. BMJ Clin Evid. 2014 Sep 29;2014:0321.
- Results publication: PubMed 16855994Moore M, Little P. Humidified air inhalation for treating croup. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD002870. doi: 10.1002/14651858.CD002870.pub2.
- Results publication: PubMed 27139290Bjornson 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.
- Derived from this study: PubMed 37525974Siebert JN, Salomon C, Taddeo I, Gervaix A, Combescure C, Lacroix L. Outdoor Cold Air Versus Room Temperature Exposure for Croup Symptoms: A Randomized Controlled Trial. Pediatrics. 2023 Sep 1;152(3):e2023061365. doi: 10.1542/peds.2023-061365.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Siebert, MD principal investigator
University Hospitals of Geneva
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor cold air exposure in people with Croup, run by Pediatric Clinical Research Platform.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Westley croup score at 30 minutes (time frame: at 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668364, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.