Children receiving Heliox Inhalation in Croup: a randomised controlled trial
| ISRCTN | ISRCTN82240782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82240782 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/10/2006
- Registration date
- 22/02/2007
- Last edited
- 29/11/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Timothy Coats
Scientific
Scientific
Emergency Department
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
| tc61@le.ac.uk |
Study information
| Study design | Randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study 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] |
| 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 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 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 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
LE1 5WW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
University/education
University/education
Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
England
United Kingdom
| djr8@le.ac.uk | |
| Website | http://www.uhl-tr.nhs.uk/ |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
