Croup Clinical Trial
Official title:
Outdoor Cold Air Exposure Versus Room Temperature for Croup Symptoms in Pediatric Emergency Departments: a Randomized Controlled Trial
Verified date | January 2023 |
Source | Pediatric Clinical Research Platform |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | May 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Months to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Pediatric Clinical Research Platform |
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.0000 — View 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. — View 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. — View Citation
Johnson DW. Croup. BMJ Clin Evid. 2014 Sep 29;2014:0321. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
at 60 minutes | |
Secondary | Pulse oxymetry | Pulse oxymetry in % | at 0 min, at 30 and at 60 minutes from enrolment at triage | |
Secondary | Respiratory rate | Respiratory rate in breaths/min | at 0 min, at 30 and at 60 minutes from enrolment at triage | |
Secondary | Heart rate | Heart rate in beats/min | at 0 min, at 30 and at 60 minutes from enrolment at triage | |
Secondary | Telephone Outpatient derived score | Anamnestic scoring tool to estimate croup severity, derived from the original Telephone Out Patient 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 | |
Secondary | Hospitalisation rate | Rate of hospital admission for croup | Within 7 days from the initial visit | |
Secondary | Adverse events | Parental or patient perception of adverse events related to exposure to outdoor cold air. | at 30 minutes from enrolment at triage |
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