Trial of nasal CPAP (Continuous Positive Airways Pressure) in infants with bronchiolitis

ISRCTN ISRCTN80797035
DOI https://doi.org/10.1186/ISRCTN80797035
Secondary identifying numbers N0205134443
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
10/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S Carr
Scientific

Paediatric department
2nd Floor, Fielden House
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Phone +44 (0)20 7377 7462
Email siobhan.carr@bartsandthelondon.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleTrial of nasal CPAP (Continuous Positive Airways Pressure) in infants with bronchiolitis
Study objectivesThis 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRespiratory: Bronchiolitis
InterventionA 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/11/2001
Completion date01/06/2005

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit1 Year
SexNot Specified
Target number of participants31
Total final enrolment31
Key inclusion criteriaChildren less than one year of age with a clinical diagnosis of bronchiolitis.
Key exclusion criteriaNo exclusion criteria
Date of first enrolment01/11/2001
Date of final enrolment01/06/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Paediatric department
London
E1 1BB
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Barts and The London NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/01/2008 Yes No

Editorial Notes

10/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.