Continuous positive airway pressure (CPAP) or Synchronised intermittent positive airway pressure (SiPAP™) study
| ISRCTN | ISRCTN15997073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15997073 |
| Protocol serial number | N/A |
| Sponsor | South Tees Hospitals NHS Trust (UK) |
| Funder | South Tees Hospitals NHS Trust (UK) - Directorate of Neonatology |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Directorate of Neonatology
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled multi-centre unblinded pilot trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 130 |
| 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
- United Kingdom
- England
Study participating centre
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/06/2016: No publications found, verifying study status with principal investigator.