Which is the most effective method of providing non-invasive respiratory support (NIRS) to preterm neonates with lung disease?
| ISRCTN | ISRCTN43771164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43771164 |
| Protocol serial number | 6532 |
| Sponsor | Brighton and Sussex University Hospitals NHS Trust (UK) |
| Funder | National Institute for Health Research |
- Submission date
- 24/06/2010
- Registration date
- 24/06/2010
- Last edited
- 11/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Medical Research Building
Biology Road
Falmer
Brighton
BN1 9PS
United Kingdom
| Phone | +44 1273 696955 |
|---|---|
| paul.seddon@bsuh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Which is the most effective method of providing non-invasive respiratory support (NIRS) to preterm neonates with lung disease? |
| Study acronym | NIRS |
| Study objectives | Non-invasive respiratory support (NIRS) is being required by increasing numbers of infants in UK neonatal units. Because of the disadvantages of intermittent positive pressure ventilation (IPPV), it is important to optimise practice so that as many infants as possible can be supported non-invasively - either completely, or after an initial short period of IPPV. A number of devices are available to provide NIRS. Three of the most widely used are CPAP, SiPAP and Optiflow. There is therefore an urgent need to compare the effectiveness of these three modes of NIRS. Although ultimately a large multicentre clinical trial will be needed, the logical and ethical first step is to compare their short-term effectiveness in a pilot study using a combination of clinical and physiological end-points. Such a study, would provide important data in itself to guide clinical practice, but would also provide essential preliminary data to design a definitive clinical trial. |
| Ethics approval(s) | MREC approved (ref: 08/H1111/18) |
| Health condition(s) or problem(s) studied | Topic: Respiratory, Generic Health Relevance and Cross Cutting Themes; Subtopic: Respiratory (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Respiratory, Paediatrics |
| Intervention | Group 1: Continuous positive airway pressure (CPAP) versus synchronised inspiratory positive airway pressure (SiPAP) Group 2: CPAP versus Optiflow |
| Intervention type | Other |
| Primary outcome measure(s) |
Provide evidence to allow clinicians to choose the most effective mode of NIRS |
| Key secondary outcome measure(s) |
1. Allow standardisation of NIRS equipment and policies across neonatal care networks |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
BN1 9PS
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 |
Editorial Notes
11/08/21016: No publications found in PubMed, verifying study status with principal investigator.
