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
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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 babys 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 babys 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22152592
2. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27371758
Publication citations
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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.