Contact information
Type
Scientific
Primary contact
Dr Paul Seddon
ORCID ID
Contact details
Medical Research Building
Biology Road
Falmer
Brighton
BN1 9PS
United Kingdom
+44 1273 696955
paul.seddon@bsuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6532
Study information
Scientific title
Which is the most effective method of providing non-invasive respiratory support (NIRS) to preterm neonates with lung disease?
Acronym
NIRS
Study hypothesis
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
MREC approved (ref: 08/H1111/18)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Provide evidence to allow clinicians to choose the most effective mode of NIRS
Secondary outcome measures
1. Allow standardisation of NIRS equipment and policies across neonatal care networks
2. Optimise work of breathing allowing infants to thrive and wean off NIRS more rapidly
3. Potentially reduce incidence and/or severity of neonatal chronic lung disease, with consequent savings in health care in early life (e.g., home oxygen)
4. Provide information to guide clinicians and managers in purchasing cost-effective equipment
5. Reduce cot days on IPPV allowing more efficient use of resources
6. Reduce likelihood of infant having to be reintubated to receive IPPV
Overall trial start date
01/11/2008
Overall trial end date
01/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2008
Recruitment end date
01/11/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medical Research Building
Brighton
BN1 9PS
United Kingdom
Sponsor information
Organisation
Brighton and Sussex University Hospitals NHS Trust (UK)
Sponsor details
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list