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
Secondary identifying numbers	6532

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

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 Paul Seddon
Scientific

Medical Research Building
Biology Road
Falmer
Brighton
BN1 9PS
United Kingdom

Phone	+44 1273 696955
Email	paul.seddon@bsuh.nhs.uk

Study information

Study design	Single centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	01/11/2008
Completion date	01/11/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Planned sample size: 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

England
United Kingdom

Study participating centre

Medical Research Building

Brighton
BN1 9PS
United Kingdom

Sponsor information

Brighton and Sussex University Hospitals NHS Trust (UK)
Hospital/treatment centre

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom

Website	http://www.bsuh.nhs.uk/

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

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

11/08/21016: No publications found in PubMed, verifying study status with principal investigator.