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ISRCTN
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ISRCTN82240782
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ClinicalTrials.gov identifier
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Public title
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Children receiving Heliox Inhalation in Croup: a randomised controlled trial
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Scientific title
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Acronym
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CHIC
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Serial number at source
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N/A
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Study hypothesis
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What effect has Heliox on improving croup score and relieving symptoms in children with croup?
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Ethics approval
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Submitted to the University Hospitals of Leicester (UHL) R&D office and Ethics Committee [UHL 10193]
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Study design
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Randomised double-blind controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Croup (laryngotracheobronchitis)
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Participants - inclusion criteria
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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).
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2007
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Anticipated end date
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01/03/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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142
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Interventions
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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.
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Primary outcome measure(s)
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Modified Westley Croup Score at 30 minutes
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Secondary outcome measure(s)
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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
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Sources of funding
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Not provided at time of registration
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Trial website
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Publications
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Contact name
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Prof
Timothy
Coats
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Address
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Emergency Department
Leicester Royal Infirmary
Infirmary Square
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City/town
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Leicester
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Zip/Postcode
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LE1 5WW
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Country
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United Kingdom
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Email
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tc61@le.ac.uk
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Sponsor
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University Hospitals of Leicester NHS Trust (UK)
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Address
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Trust Headquarters
Gwendolen House
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4QF
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Country
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United Kingdom
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Email
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djr8@le.ac.uk
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Sponsor website:
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http://www.uhl-tr.nhs.uk/
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Date applied
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07/10/2006
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Last edited
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26/06/2008
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Date ISRCTN assigned
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22/02/2007
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