Condition category
Respiratory
Date applied
07/10/2006
Date assigned
22/02/2007
Last edited
29/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Heliox21

Primary outcome measures

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 trial start date

01/03/2007

Overall trial end date

01/03/2010

Reason abandoned

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

Patient

Age group

Child

Gender

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

United Kingdom

Trial 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
United Kingdom
djr8@le.ac.uk

Sponsor type

University/education

Website

http://www.uhl-tr.nhs.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes