Randomised controlled trial of Bubble CPAP versus infant flow driver for successful extubation in preterm infants
| ISRCTN | ISRCTN83339638 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83339638 |
| Secondary identifying numbers | N0227165400 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 15/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Samir Gupta
Scientific
Scientific
South Tees Hospital Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To compare the efficacy and safety of two different systems of delivering nasal continuous positive airway pressure for successful extubation of preterm infants. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases: Respiratory |
| Intervention | Babies up to 30 week gestation and requiring ventilatory support would be eligible for study pre-extubation. Signed informed parental consent will be sought before randomisation.Babies will be randomised onto one of the currently used CPAP modes: Infant Flow Driver or Bubble CPAP. Nursing care including monitoring will be as per unit protocols. The successful extubation (primary outcome) will be analysed as per pre-defined clinical and physiological criteria. Each group will be analysed based on duration of ventilation (less than and equal to 2 weeks, and more than 2 weeks). Total number of babies required will be 59 each group. |
| Intervention type | Other |
| Primary outcome measure | Respiratory failure within 72 hours defined as: 1. Need for re-intubation primarily for respiratory distress AND/OR 2. Uncompensated Respiratory Acidosis (pH<7.2 AND pCO2>8kPa |
| Secondary outcome measures | 1. Endotracheal reintubation 2. Duration of CPAP days 3. Chronic Lung Disease, Morbidity, Mortality and Data on complications including gastrointestinal will be collected. |
| Overall study start date | 01/10/2004 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Total number of babies required will be 59 each group |
| Key inclusion criteria | 1. Born between 24 and less than 30 weeks gestation, or with a birth weight of 600 to 1500 grams 2. Endotracheal intubation for any duration 3. Stable or improving respiratory status with inspired oxygen concentration of less than 50% 4. First extubation attempt 5. Signed parental consent 6. Considered ready for extubation by the clinical management team |
| Key exclusion criteria | 1. Major congenital malformations, which are known to adversely affect life expectancy 2. Known congenital or acquired upper airway obstruction 3. Neuromuscular disorders |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 30/06/2007 |
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 (UK)
No information available
NHS R&D Support Funding (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | Yes | No |
