A randomised controlled trial of nasal constant positive airway pressure (NCPAP) as primary therapy for respiratory distress syndrome (RDS) in very pre-term infants.
| ISRCTN | ISRCTN68552342 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68552342 |
| Secondary identifying numbers | N0128138699 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 29/08/2012
- 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
Not provided at time of registration
Contact information
Prof Richard Cooke
Scientific
Scientific
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
| Phone | +44 (0)151 708 9988 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study hypothesis | Early intubation and surfactant therapy followed by extubation to NCPAP in preterm infants of less than 29 weeks gestation with RDS when compared to continued intubation and intermittent positive pressure ventilation (IPPV) will result in a 50% reduction in chronic lung disease (CLD) (O2 dependency at 36 weeks post menstrual age). |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Neonatal Diseases: Respiratory |
| Intervention | Early intubation and surfactant therapy followed by extubation to NCPAP compared with continued intubation and intermittent positive pressure ventilation (IPPV) |
| Intervention type | Other |
| Primary outcome measure | Proportion of infants receiving added oxygen and/or respiratory support at 36 weeks post menstrual age. |
| Secondary outcome measures | 1. Days of respiratory support 2. Days of added oxygen 3. Death 4. Pneumothorax rate 5. Sepsis rate (positive blood culture) 6. Trauma rates (nasal septal injury, tracheal stenosis) 7. Change in weight and head circumference centiles between birth and discharge (Z scores). |
| Overall study start date | 07/10/2003 |
| Overall study end date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 200 infants |
| Participant inclusion criteria | 200 infants |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 07/10/2003 |
| Recruitment end date | 01/03/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
L8 7SS
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Liverpool Women's Hospital NHS Trust (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 |
