Pressure Support Ventilation (PSV) for ventilation of newborn infants
| ISRCTN | ISRCTN44873935 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44873935 |
| Protocol serial number | N0436130508 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K Tan
Scientific
Scientific
Neonatal Unit
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 243 3144 |
|---|---|
| k.tan@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Pressure Support Ventilation (PSV) for ventilation of newborn infants |
| Study objectives | To investigate if PSV performs as well as conventional trigger ventilation modes (SIPPV, SIMV) in supporting newborn infants receiving mechanical ventilation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases: Respiratory |
| Intervention | 1. Synchronised intermittent positive pressure ventilation (SIPPV) 2. Synchronised intermittent mandatory ventilation (SIMV) |
| Intervention type | Other |
| Primary outcome measure(s) |
A change in mean airway pressure. |
| Key secondary outcome measure(s) |
Oxygenation index (OI), comfort score, tidal volumes, PaCO2, degree of asynchrony during exhalation. |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Key inclusion criteria | Newborn infants in the convalescent phase of respiratory distress syndrome and being weaned from mechanical ventilation |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/04/2003 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Neonatal Unit
Leeds
LS9 7TF
United Kingdom
LS9 7TF
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/05/2017: No publications found, study status unverified
