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
Scientific
Paediatric department
2nd Floor, Fielden House
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
| Phone | +44 (0)20 7377 7462 |
|---|---|
| siobhan.carr@bartsandthelondon.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Trial of nasal CPAP (Continuous Positive Airways Pressure) in infants with bronchiolitis |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2001 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 1 Year |
| Sex | Not Specified |
| Target number of participants | 31 |
| Total final enrolment | 31 |
| Key inclusion criteria | Children less than one year of age with a clinical diagnosis of bronchiolitis. |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Paediatric department
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Department of Health
Government
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 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 | Not 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.
