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

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Suresh Victor


Contact details

St Mary's Hospital
Manchester Royal Infirmary
Oxford Road
M13 9WL
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial of nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks gestation



Study hypothesis

Babies born prematurely have breathing difficulties for which they need support from a machine called ventilator. The ventilator gives them regular breaths through a breathing tube placed in the wind pipe. The process of removing the tube or extubation and allowing the baby to breathe on his/her own does not always go to plan. Around one-fourth of babies need to have the breathing tube replaced in the wind pipe. The process of replacing the tube can be traumatic and spending more time on the ventilator can damage the baby’s immature lungs. Continuous Positive Airway Pressure (n-CPAP) and Biphasic Positive Airway Pressure (n-BiPAP) are ways of supporting breathing that are less invasive - they use tubes that go only a few millimetres into the nostril. n-CPAP produces a constant pressure at the nose that is transmitted to the lungs. n-BiPAP produces a constant pressure and also gives extra breaths. We want to find out if these extra breaths will give the baby the added support needed to stay off the ventilator.

We will conduct a randomised trial at several regional centres in the north-west of England. Babies born before 30 weeks’ gestation and less than two weeks old will be eligible to participate in the study. We will randomly assign babies to receive either n-CPAP or n-BiPAP to see which of these devices allows the baby to breathe most comfortably and stay off the ventilator.

Early and successful extubation would mean that premature babies will spend less time on the ventilator. This will reduce the chances of injury to the baby’s lungs and allow for more efficient use of intensive care cots at referral centres. It would also mean that babies can be moved earlier to centres closer to home.

Ethics approval

North West 11 Research ethics committee, Preston approved on 4th Jan 2011, 10/H1016/145

Study design

Randomised; Interventional; Design type: Not specified

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Topic: Reproductive Health and Childbirth, Generic Health Relevance and Cross Cutting Themes; Subtopic: Reproductive Health and Childbirth (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Reproductive Health & Childbirth, Paediatrics


BiPAP: The BiPAP group will receive at extubation a mean airway pressure of 6 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 8 cms of water). Inspiratory time of one second and respiratory rate of 30/ min will always be maintained.

CPAP: The CPAP group will receive at extubation a single level continuous positive airway pressure of 6 cm water for at least 48 hours before weaning is commenced.

Study Entry: Single Randomisation only

Intervention type



Not Applicable

Drug names

Primary outcome measures

Extubation Failure; Timepoint(s): This will be defined as: Uncompensated respiratory acidosis defined as pH less than 7.2

Secondary outcome measures

1. Maintenance of successful extubation for 7 days
2. Total days on ventilator, n-CPAP/ n-BiPAP
3. Number of ventilator days following first extubation attempt
4. Oxygen requirement at 28 days of age and at 36 weeks of corrected gestation
5. pH, partial pressure of carbon dioxide in the first post extubation gas
6. Duration of hospitalisation
7. Rates of abdominal distension requiring cessation of feeds for 7 days post extubation
8. Rate of apnoea and bradycardia expressed as events per hour during the 48 hours following extubation
9. Age at transfer back to referral centre in days

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Born before 30 weeks’ gestation
2. Ventilated through an endotracheal tube
3. Less than two weeks old
4. First attempt at extubation
Target Gender: Male & Female; Upper Age Limit 30 weeks ; Lower Age Limit 23 weeks

Participant type


Age group




Target number of participants

Planned Sample Size: 540; UK Sample Size: 540;

Participant exclusion criteria

1. Presence of major congenital malformations
2. Presence of neuromuscular disease
3. Presence of known upper respiratory tract abnormalities
4. Likely to be within 7 days post-operative
5. Presence of intraventricular haemorrhage with parenchymal extension

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital
M13 9WL
United Kingdom

Sponsor information


Central Manchester University Hospitals NHS Trust (CMFT) (UK)

Sponsor details

St Mary's Hospital
Manchester Royal Infirmary
Oxford Road
M13 9WL
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK)- Research for Patient Benefit Grant

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

Results - basic reporting

Publication summary

1. 2011 protocol in

Publication citations

  1. Protocol

    Victor S, , EXTUBATE: a randomised controlled trial of nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks' gestation: study protocol for a randomised controlled trial., Trials, 2011, 12, 257, doi: 10.1186/1745-6215-12-257.

Additional files

Editorial Notes