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
Pressure Support Ventilation (PSV) for ventilation of newborn infants
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
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