Continuous positive airway pressure (CPAP) or Synchronised intermittent positive airway pressure (SiPAP™) study
| ISRCTN | ISRCTN15997073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15997073 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/01/2009
- Registration date
- 12/02/2009
- Last edited
- 16/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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 Fiona Wood
Scientific
Scientific
Directorate of Neonatology
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Study information
| Study design | Randomised controlled multi-centre unblinded pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial of synchronised intermittent positive airway pressure (SiPAP™) versus continuous positive airway pressure (CPAP) as a primary mode of respiratory support in preterm infants with respiratory distress syndrome (RDS) |
| Study acronym | CoSi Study |
| Study objectives | The purpose of this study is to compare synchronised intermittent positive airway pressure (SiPAP™) with continuous positive airway pressure (CPAP) as a primary mode of non-invasive respiratory support, in premature newborn infants with respiratory distress syndrome (RDS). We hypothesise that the use of SiPAP™ will result in a reduction in the rates of endotracheal intubation and mechanical ventilation. |
| Ethics approval(s) | County Durham and Tees Valley 1 REC, 11/02/2009, ref: 09/H0905/4 Amendments approved: 23/02/2009 |
| Health condition(s) or problem(s) studied | Respiratory distress syndrome |
| Intervention | Two modes of non-invasive ventilation: 1. Continuous positive airway pressure - active control 2. Synchronised intermittent positive airway pressure (SiPAP™) - intervention Treatment will be until non-invasive respiratory support has been discontinued and the baby has remained stable off non-invasive support for more than 7 days or where the baby has failed on non-invasive respiratory support and been intubated and mechanically ventilated. Follow-up will be until the time of final discharge home but not beyond. |
| Intervention type | Other |
| Primary outcome measure | Failure of non-invasive ventilation necessitating intubation and mechanical ventilation (placement of a tube in the windpipe and full artificial breathing support via machine) in the first 72 hours of treatment with either CPAP or SiPAP™. This outcome is binary categoric as babies will be either 'intubated and mechanically ventilated' or not; providing a proportion of infants in each treatment arm who meet this outcome. |
| Secondary outcome measures | Assessed from the medical notes and nursing charts at discharge they all constitute usual care of preterm infants at these gestations, who are intensive care level patients and continuously monitored whilst receiving respiratory support. It is impossible to specify an exact timepoint for many of the outcomes as they can occur at any time for these infants, hence an assessment of the occurrence or not of the outcome on discharge by reviewing the case notes. 1. Death prior to discharge - at time of death 2. RDS severity grading - at randomisation 3. Reason for failure of non-invasive ventilation -at failure 4. Timing of failure of non-invasive ventilation - at failure 5. Total duration of any form of respiratory support - at discharge - review of notes 6. Duration of invasive mechanical ventilation - at discharge - review of notes 7. Duration of supplemental oxygen - at discharge - review of notes 8. Bronchopulmonary dysplasia (diagnosis) - at 36 weeks gestation 9. Pneumothorax (diagnosis) - at discharge - review of notes 10. Postnatal steroid use - at discharge - review of notes 11. Necrotising enterocolitis diagnosis - at discharge - review of notes 12. Necrotising enterocolitis needing surgery - at discharge - review of notes 13. Gastric distension - assessed clinically 6-8 hourly whilst on non-invasive ventilation, outcome assessed at discharge - review of notes 14. Sepsis diagnosis - at discharge - review of notes 15. Nasal injuries - assessed clinically 6 - 8 hourly whilst on non-invasive ventilation, outcome assessed at discharge - review of notes 16. Nasal injuries - grading and treatment required, at discharge - review of notes 17. Retinopathy of prematurity - greater than grading and treatment (surgery), at discharge - review of notes 18. Patent ductus arteriosus - greater than treatment required, at discharge - review of notes 19. Abnormal cranial ultrasound scan - report worst scan for grading, at discharge - review of notes 20. Cranial abnormalities periventricular leukomalacia (PVL) or intraventricular haemorrhage (IVH) - at discharge - review of notes 21. Time to full enteral feeds - in days to reach 150 ml/kg/day, at discharge - review of notes 22. Change in weight from birth to 36 weeks postmenstrual age - Z scores, at discharge - review of notes 23. Change in weight from birth to discharge - Z scores at discharge - review of notes 24. Length of hospital stay - at discharge - review of notes 25. Duration of intensive and high dependency care - at discharge - review of notes |
| Overall study start date | 02/03/2009 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Total recruitment = 130 preterm infants |
| Key inclusion criteria | 1. Gestational age - 28+0 to 31+6 weeks by scan estimated date of delivery (EDD) inclusive 2. Signs of respiratory distress requiring non-invasive respiratory support 3. Inborn 4. Signed written parental consent for participation 5. Randomised by 6 hours of age or less |
| Key exclusion criteria | 1. Gestational age - less than 27+6 weeks or greater than 32+0 weeks 2. Endotracheal intubation and ventilation at any time prior to enrolment 3. Respiratory distress meeting failure criteria of non-invasive ventilation and requiring intubation and mechanical ventilation 4. Congenital or neuromuscular disorders diagnosed antenatally or at the time of birth, known to interfere with respiratory function or ability to breathe; including significant abnormalities of the upper airway 5. Refusal of signed written parental consent |
| Date of first enrolment | 02/03/2009 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Directorate of Neonatology
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Sponsor information
South Tees Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
James Cook University Hospital
Marton Road
Middelsbrough
TS4 3BW
England
United Kingdom
| Website | http://www.southtees.nhs.uk/live/ |
|---|---|
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Government
South Tees Hospitals NHS Trust (UK) - Directorate of Neonatology
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 |
Editorial Notes
16/06/2016: No publications found, verifying study status with principal investigator.
