Randomised controlled trials and feasibility studies for newer modes of artificial ventilation in newborns with respiratory failure
| ISRCTN | ISRCTN40254851 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40254851 |
| Protocol serial number | N0227097989 |
| Sponsor | Department of Health |
| Funder | South Tees Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 26/04/2011
- 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
Prof Sunil Sinha
Scientific
Scientific
Women & Children Division
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 854874 |
|---|---|
| s.k.sinha@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the efficacy and safety of these newer modes of artificial ventilation, and assess their superiority over conventional ventilation in terms of mortality, analysis of cost of treatment, and short and long term respiratory outcome. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory failure |
| Intervention | Randomised controlled trial of different modes of ventilation. Patients were randomised to different modes of ventilation, or the conventional ventilation methods. |
| Intervention type | Other |
| Primary outcome measure(s) | Duration of ventilation and weaning |
| Key secondary outcome measure(s) | No secondary outcome measures |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | Babies less than 1500 g with respiratory distress syndrome (RDS) requiring ventilation |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Women & Children Division
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2006 | Yes | No | |
| Results article | results | 01/03/2007 | Yes | No | |
| Results article | results | 01/03/2009 | Yes | No | |
| Results article | results | 01/09/2009 | Yes | No |
