Condition category
Respiratory
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
11/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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