Children receiving Heliox Inhalation in Croup: a randomised controlled trial

ISRCTN	ISRCTN82240782
DOI	https://doi.org/10.1186/ISRCTN82240782
Protocol serial number	N/A
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Timothy Coats
Scientific

Emergency Department
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Email	tc61@le.ac.uk

Primary study design	Interventional
Study design	Randomised double-blind controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CHIC
Study objectives	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]
Health condition(s) or problem(s) studied	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Heliox21
Primary outcome measure(s)	Modified Westley Croup Score at 30 minutes
Key secondary outcome measure(s)	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
Completion date	01/03/2010
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	5 Years
Sex	Not Specified
Target sample size at registration	142
Key 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).
Key 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
Date of first enrolment	01/03/2007
Date of final enrolment	01/03/2010

Emergency Department

Leicester
LE1 5WW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan