Condition category
Respiratory
Date applied
23/02/2011
Date assigned
08/03/2011
Last edited
17/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Most premature infants need breathing support through a tube in their wind pipe. We know providing artificial breathing support can lead to long-term problems with the growth of the lungs. Although most clinicians would agree when to start breathing support for a preterm infant, there is as yet no consensus on when to reduce this support, also called ‘weaning on mechanical ventilation’. This study is investigating two different methods of ‘weaning’ breathing support in premature infants. Until recently, most units in the UK used synchronised intermittent mandatory ventilation (SIMV). SIMV matches a fixed number of breaths on the breathing support machine and over a period of time the fixed number of breaths is reduced before the breathing tube is taken out (extubation). However, advances in technology have led to newer modes of ventilation. One such mode is pressure support ventilation (PSV). In PSV the infant is in charge of all aspects of breathing. The medical team would only set the permissible pressure level to support the spontaneous breaths, so weaning on mechanical ventilation would only be to decrease the pressure support before the tube is taken out. In adults PSV is preferred as this is more comfortable.

Who can participate?
Preterm infants born between 23+0 weeks and 32 weeks gestation who were ventilated for at least 6 hours for Respiratory Distress Syndrome (RDS).

What does the study involve?
Participating infants will be randomly allocated to one of the two modes of ‘weaning’ breathing support. It is usual for some infants to not tolerate the reduction in breathing support and ‘fail’. If at any stage the infant does not tolerate any of the weaning methods then the medical team would assess them as per usual policy. All other aspects of their care would be provided as per unit policy and current practice.

What are the possible benefits and risks of participating?
At present there is no perceived benefit or risk of one method over the other. However, at the end of the study both the groups would be compared to find out if there is a difference.

Where is the study run from?
University Hospital of North Tees and James Cook University Hospital (UK).

When is the study starting and how long is it expected to run for?
From January 2010 to May 2013.

Who is funding the study?
University Hospital of North Tees (UK).

Who is the main contact?
Prof. Samir Gupta
samir.gupta@nth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Samir Gupta

ORCID ID

Contact details

Neonatal Unit
University Hospital of North Tees
Hardwick Road
Stockton
TS19 8PE
United Kingdom
+44 (0)16 4262 4250
samir.gupta@nth.nhs.uk

Type

Scientific

Additional contact

Dr Prashant Mallya

ORCID ID

Contact details

Neonatal Unit
University Hospital of North Tees
Hardwick Road
Stockton
TS19 8PE
United Kingdom
+ 44 (0)16 4262 4248
mallyaprashant@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 13, 29/12/2010

Study information

Scientific title

Pressure Support Ventilation (PSV) or Synchronised Intermittent Mandatory Ventilation (SIMV) for weaning preterm infants on mechanical ventilation: a multi-centre randomised controlled trial

Acronym

POST-UK Study

Study hypothesis

The trial is investigating the practicability of PSV as opposed to SIMV for weaning on mechanical ventilation in preterm infants needing mechanical ventilatory support for Respiratory Distress Syndrome (RDS).

The primary endpoint of the trial is defined as time from entry into the trial (predefined priori of mean airway pressure of less than 10cms, oxygen requirement of less than 40% and spontaneous breath rates of at least 50%) to the time when the infant is ready for extubation demonstrated by passing then minute ventilation test (MVT).

The null hypothesis for the trial would find no difference between the two modes. However any difference between the two modes would be calculated using appropriate statistical calculations.

The study is planned across two tertiary care units in the North East of England.

Ethics approval

Newcastle and North Tyneside Research Ethics Committee, 10/01/2011

Study design

Multi-centre 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

Respiratory distress syndrome in preterm babies

Intervention

The intervention arm would receive pressure supported mechanical breaths for all the spontaneous breaths generated by the infant and the control arm would receive SIMV mode of respiratory support as is currently practiced.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

The primary endpoint is duration of weaning on mechanical ventilation - defined as time from commencing weaning in the assigned mode of respiratory support to the time when the infant is ready for extuabtion demonstrated by passing the MVT

Secondary outcome measures

1. Total duration of mechanical support through the endotracheal (ET) tube
2. Total duration of respiratory support including non invasive respiratory support
3. Discharge on home oxygen
4. Complications of prematurity

Overall trial start date

26/01/2011

Overall trial end date

26/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Preterm infants with RDS, stratified into three groups (23+0 to 25+6, 26+0 to 28+6 and 29+0 to 31+6 weeks) based on their gestation at birth would be enrolled if they are needing mechanical ventilation through an endotracheal tube for at least 6 hours
2. Signed parental consent is obtained before randomisation

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Severe congenital malformation
2. Neuromuscular disorder demonstrated clinically with decreased muscular tone
3. Upper airway anomaly
4. Infants transferred from other unit who have met the study entry criteria on admission to the neonatal unit

Recruitment start date

26/01/2011

Recruitment end date

26/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of North Tees
Stockton
TS19 8PE
United Kingdom

Sponsor information

Organisation

North Tees and Hartlepool NHS Foundation Trust (UK)

Sponsor details

Univeristy Hospital of North Tees
Hardwick Road
Stockton
TS19 8PE
United Kingdom
+44 (0)16 4238 3251
jane.greenaway@nth.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of North Tees (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Data analysis is ongoing. All aspects of the study would be sent for publication including the study protocol. The researchers aim to disseminate the research findings in 2016.

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes