Condition category
Neonatal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Irfan Ulhaq Cheema


Contact details

Box No 226
Rosie Maternity Hospital
United Kingdom
+44 (0)1223 217 617 ext 6275

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

To investigate if Pressure Support Ventilation (PSV) performs as well as conventional trigger ventilation modes synchronised intermittent mandatory ventilation (SIMV) and synchronised intermittent positive pressure ventilation (SIPPV), in supporting newborn infants receiving mechanical ventilation.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Neonatal Diseases: Ventilation


Consent would be sought to participate in the study.

The patient would be eligible to commence the study when in a stable condition with an inspired oxygen concentration of less than or equal to 60% and a decision made by the treating clinician to commence weaning from the ventilator.

Patients on the neonatal unit at The Rosie maternity hospital are ventilated on the synchronised triggered ventilation modes of either synchronised intermittent mandatory ventilation (SIMV) or synchronised intermittent positive pressure ventilation (SIPPV). If the patient is on SIMV, their mode of ventilation will be altered to SIPPV (provided the patient is receiving a supported respiratory rate of greater than 40 breaths per minute, this will be equivalent to SIMV). If the patient is originally ventilated on SIMV and hence changed to SIPPV, a 1 hour period will be allowed prior to commencing the study in order for the patient to settle.

Once the study begins each infant will be allocated randomly to a start mode, with half of the patients starting on SIPPV and the other half starting on pressure support ventilation (PSV).

PSV is a mode of ventilation which allows each patient breath to be both patient initiated and patient terminated, therefore the patient sets the duration of their own inspiratory time. Each patient breath is supported by the ventilator. In the conventional modes of ventilation, SIMV and SIPPV each breath is again supported and is patient initiated but is ventilator terminated, the patient receives a preset inspiratory time, set by the clinician.

The ventilator settings on changing from SIPPV to PSV will be left unchanged except the inspiratory time will be increased to 0.5 seconds during the PSV mode. This is a limit on the maximum inspiratory time and will allow for a sighing respiration. Changing a patient from SIPPV to PSV and vice versa only requires the pressing of a switch on the Dräger 8000 plus ventilator.

The patient will remain on the initial mode of ventilation for 60 minutes and will then change to the alternate mode of ventilation for another 60 minute period.

During the study the newborns will receive standard intensive care monitoring, this will include measures of their heart rate and blood pressure, in addition each infant will have continuous monitoring of their blood carbon dioxide and oxygen concentrations by a transcutaneous monitor. This is a small 0.5 cm diameter probe attached to the skin and is a standard piece of monitoring equipment in the intensive care setting. In addition to the physiological parameters mentioned, during the study the patients will be observed for their level of comfort. In a few cases to verify the reproducibility of our comfort scores a video of the newborns will be taken. They will be used solely for this purpose and will be destroyed following the study.

During the study, data will be collected directly from the ventilators to analyse subsequently for various ventilator dependent parameters.

After the 2 hour study period the patient will be continued on the ventilatory mode chosen by the clinician.

This study requires few additional procedures beyond the routine care carried out on the neonatal unit. A blood gas will be taken prior to commencing the study, but we will restrict the timing of our study to coincide with when this would be routinely required. Other 'procedures' additional to routine care would be the use of a transcutaneous monitor (if the infant did not have one already attached) and the collection of data from the Drager ventilator and patient monitor, both of which are completely non invasive.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Not provided at time of registration

Participant type


Age group




Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Box No 226
United Kingdom

Sponsor information


Department of Health

Sponsor details

Richmond House
79 Whitehall
United Kingdom

Sponsor type




Funder type


Funder name

Cambridge Consortium - Addenbrooke's (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2007 results in:

Publication citations

  1. Results

    Cheema IU, Sinha AK, Kempley ST, Ahluwalia JS, Impact of volume guarantee ventilation on arterial carbon dioxide tension in newborn infants: a randomised controlled trial., Early Hum. Dev., 2007, 83, 3, 183-189, doi: 10.1016/j.earlhumdev.2006.05.013.

Additional files

Editorial Notes