Contact information
Type
Scientific
Primary contact
Dr S Carr
ORCID ID
Contact details
Paediatric department
2nd Floor
Fielden House
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
+44 (0)20 7377 7462
siobhan.carr@bartsandthelondon.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205134443
Study information
Scientific title
Acronym
Study hypothesis
This study aims to identify which treatment modality (CPAP [Continuous Positive Airways Pressure] or traditional supportive management) is more successful in infants with bronchiolitis.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Respiratory: Bronchiolitis
Intervention
A pilot study. A randomised cross-over design will be used. Infants who have reached the inclusion criteria will be randomised to either 12 hours of CPAP or 12 hours of traditional supportive management. They will then cross over into the other arm, to act as their own controls, and receive further hours of the opposite treatment. After 24 hours their clinical management will be as of the team looking after the child.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Change in partial pressure of Carbon dioxide (pCO2)
2. Change in Fraction of inspired Oxygen (FiO2)
3. Change in heart rate
4. Change in respiratory rate
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2001
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Children less than one year of age with a clinical diagnosis of bronchiolitis.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
31
Participant exclusion criteria
No exclusion criteria
Recruitment start date
01/11/2001
Recruitment end date
01/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Paediatric department
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and The London NHS Trust (UK)
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
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17344251
Publication citations
-
Thia LP, McKenzie SA, Blyth TP, Minasian CC, Kozlowska WJ, Carr SB, Randomised controlled trial of nasal continuous positive airways pressure (CPAP) in bronchiolitis., Arch. Dis. Child., 2008, 93, 1, 45-47, doi: 10.1136/adc.2005.091231.