Impact of Cold Air Exposure on Croup Symptoms

NCT05668364 | Completed

• 1 other identifier: 2016-00845
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Croup

Keywords

Croup; Laryngitis; Laryngotracheitis; Laryngotracheobronchitis; Pediatrics; Children; Infant; Cold air

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Westley croup score at 60 minutes

  at 60 minutes

• Pulse oxymetry

  at 0 min, at 30 and at 60 minutes from enrolment at triage

• Respiratory rate

  at 0 min, at 30 and at 60 minutes from enrolment at triage

• Heart rate

  at 0 min, at 30 and at 60 minutes from enrolment at triage

• Telephone Outpatient derived 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

Study Arms (2)

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.

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.

Interventions

Outdoor cold air exposure OTHER

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.

Exposition group

Eligibility Criteria

• Age: 3 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- children from 3 months to 10 years with clinical signs of croup and Westley croup score \> or =2

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatric Clinical Research Platform: lead

Related Publications (6)

• 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.

  PMID: 30133690 BACKGROUND

• 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.

  PMID: 31442871 RESULT

• Johnson DW. Croup. BMJ Clin Evid. 2014 Sep 29;2014:0321.

  PMID: 25263284 RESULT

• 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.

  PMID: 16855994 RESULT

• 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.

  PMID: 27139290 RESULT

• Siebert 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.

  PMID: 37525974 DERIVED

MeSH Terms

Conditions

Croup; Laryngitis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections

Study Officials

• Johan Siebert, MD

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of the Pediatric Emergency Department

Model Details: Open-label randomized controlled study

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 29, 2022
• Study Start: November 1, 2016
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.