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 |
| Protocol serial number | N0227165400 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | South Tees Hospitals NHS Trust (UK), NHS R&D Support Funding (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) | 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 |
| Key secondary outcome measure(s) | 1. Endotracheal reintubation 2. Duration of CPAP days 3. Chronic Lung Disease, Morbidity, Mortality and Data on complications including gastrointestinal will be collected. |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 118 |
| 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
- United Kingdom
- England
Study participating centre
South Tees Hospital Trust
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 | 01/05/2009 | Yes | No |
