Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
09/10/2014
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

Dr K Tan

ORCID ID

Contact details

Neonatal Unit
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
k.tan@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130508

Study information

Scientific title

Acronym

Study hypothesis

To investigate if PSV performs as well as conventional trigger ventilation modes (SIPPV, SIMV) in supporting newborn infants receiving mechanical ventilation.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neonatal Diseases: Respiratory

Intervention

1. Synchronised intermittent positive pressure ventilation (SIPPV)
2. Synchronised intermittent mandatory ventilation (SIMV)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

A change in mean airway pressure.

Secondary outcome measures

Oxygenation index (OI), comfort score, tidal volumes, PaCO2, degree of asynchrony during exhalation.

Overall trial start date

30/04/2003

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Newborn infants in the convalescent phase of respiratory distress syndrome and being weaned from mechanical ventilation

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/04/2003

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neonatal Unit
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

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