Contact information
Type
Scientific
Contact name
Prof Timothy Coats
ORCID ID
Contact details
Emergency Department
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
tc61@le.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CHIC
Study hypothesis
What effect has Heliox on improving croup score and relieving symptoms in children with croup?
Ethics approval(s)
Submitted to the University Hospitals of Leicester (UHL) R&D office and Ethics Committee [UHL 10193]
Study design
Randomised double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Croup (laryngotracheobronchitis)
Intervention
Patients will be randomly allocated to receiving ,additionally to the standard croup treatment, either Heliox21 (study group) or Air (control group). Comparison will be made of the primary and secondary outcome measures, comparing all those allocated to Heliox versus those allocated to Air.
29/11/2012: Please note that this trial was never started due to a lack of funding.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Heliox21
Primary outcome measure
Modified Westley Croup Score at 30 minutes
Secondary outcome measures
1. Croup score at 15 minutes
2. Respiratory rate at 15, 30 minutes
3. Parents assessment of change on Visual Analog Scale
4. Number of epinephrine nebulisers given
5. Requirement for supplemental oxygen therapy
6. Admission to hospital
7. Intubation rate
8. Length of stay in ED
9. Length of stay in hospital
10. Subsequent use of health services
Overall study start date
01/03/2007
Overall study end date
01/03/2010
Reason abandoned (if study stopped)
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
Children, aged six months to five years, presenting to the Emergency Department (ED) with moderate to severe croup (Modified Westley Croup Score of two or more).
Participant type(s)
Patient
Age group
Child
Lower age limit
6 Months
Upper age limit
5 Years
Sex
Not Specified
Target number of participants
142
Participant exclusion criteria
1. Children whose oxygen saturation is less than 95%
2. Children with known pre-existing lung or airway disease, congenital heart disease, or features suggesting other causes of stridor, such as peritonsillar abscess, epiglottitis or inhaled foreign body
Recruitment start date
01/03/2007
Recruitment end date
01/03/2010
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Emergency Department
Leicester
LE1 5WW
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
England
United Kingdom
djr8@le.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|