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

ISRCTN ISRCTN00171143
DOI https://doi.org/10.1186/ISRCTN00171143
Protocol serial number N0201170878
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Funders Royal Brompton and Harefield NHS Trust (UK), Clinical Research Committee, NHS R&D Support Funding
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
18/05/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
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

Miss Ruth Helen Wakeman
Scientific

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

Phone +44 (0)20 7351 8088/8436
Email r.wakeman@rbht.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleA randomised trial of elective continuous positive airway pressure (CPAP) verses rescue CPAP after extubation in infants following cardiac surgery
Study objectivesElective 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNeonatal Diseases
InterventionExtubation of immediate nasal CPAP, extubation to face non-pressurised oxygen therapy only
Intervention typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date12/02/2007

Eligibility

Participant type(s)Patient
Age groupNeonate
SexAll
Target sample size at registration110
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment13/02/2006
Date of final enrolment12/02/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

18/05/2017: No publications found in PubMed, verifying study status with principal investigator.