Physiologic measurements using continuous neonatal blood gas monitoring in preterm infants requiring mechanical ventilation for respiratory failure
| ISRCTN | ISRCTN64017166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64017166 |
| Secondary identifying numbers | N0227165397 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 27/01/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 M K Lal
Scientific
Scientific
South Tees Hospital Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 282724 |
|---|---|
| Mithilesh.lal@stees.nhs.uk |
Study information
| Study design | Single centre randomised crossover clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Variability in arterial PsO2 and PaCO2 as measured continuously by multiparameter arterial sensor (NeotrendR) in babies on different modes of mechanical ventilation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases |
| Intervention | Single-centre randomised crossover clinical trial. Updated 27/01/2014: This trial was stopped because the manufacturers of the Neotrend/Paratrend device used for continuous blood gas monitoring went out of business and the product was no longer available. |
| Intervention type | Other |
| Primary outcome measure | Coefficient of variation in blood gases (PaO2 and PaC02) while receiving mechanical ventilation. |
| Secondary outcome measures | Incidental physiological data that are routinely collected in babies requiring intensive care, such as core temperature, arterial PH. |
| Overall study start date | 01/06/2005 |
| Completion date | 31/12/2006 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 10 |
| Key inclusion criteria | Preterm newborn infants < 34 weeks gestation, requiring mechanical ventilation for respiratory failure. |
| Key exclusion criteria | All babies not receiving mechanical ventilation for respiratory failure. |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
South Tees Hospital Trust
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
South Tees Hospitals NHS Trust
No information available
The James Cook University Hospital
No information available
NHS R&D Support Funding
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 |
