Condition category
Neonatal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
08/10/2014
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

Miss Ruth Helen Wakeman

ORCID ID

Contact details

Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8088/8436
r.wakeman@rbht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0201170878

Study information

Scientific title

A randomised trial of elective continuous positive airway pressure (CPAP) verses rescue CPAP after extubation in infants following cardiac surgery

Acronym

Study hypothesis

Elective use of nasal CPAP following tracheal extubation will reduce the incidence of the need for reintubation within 72 hours of primary tracheal extubation.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neonatal Diseases

Intervention

Extubation of immediate nasal CPAP, extubation to face non-pressurised oxygen therapy only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

13/02/2006

Overall trial end date

12/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

110

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

13/02/2006

Recruitment end date

12/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton & Harefield NHS Trust
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Brompton and Harefield NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Clinical Research Committee

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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