Condition category
Neonatal Diseases
Date applied
07/06/2011
Date assigned
07/06/2011
Last edited
12/01/2012
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 Suresh Victor

ORCID ID

Contact details

St Mary's Hospital
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
suresh.victor@cmft.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10146

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

Acronym

EXTUBATE

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

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

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

Intervention

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

Other

Phase

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

01/04/2011

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

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

Patient

Age group

Neonate

Gender

Both

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

01/04/2011

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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

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

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22152592

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