Nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks gestation

ISRCTN	ISRCTN18921778
DOI	https://doi.org/10.1186/ISRCTN18921778
Protocol serial number	10146
Sponsor	Central Manchester University Hospitals NHS Trust (CMFT) (UK)
Funder	National Institute for Health Research (NIHR) (UK)- Research for Patient Benefit Grant

Submission date: 07/06/2011
Registration date: 07/06/2011
Last edited: 08/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Suresh Victor
Scientific

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

Email	suresh.victor@cmft.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Not specified
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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 acronym	EXTUBATE
Study objectives	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(s)	North West 11 Research ethics committee, Preston approved on 4th Jan 2011, 10/H1016/145
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Extubation Failure; Timepoint(s): This will be defined as: Uncompensated respiratory acidosis defined as pH less than 7.2
Key secondary outcome measure(s)	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
Completion date	31/03/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	540
Key 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
Key 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
Date of first enrolment	01/04/2011
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Mary's Hospital

Manchester
M13 9WL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2016		Yes	No
Protocol article	protocol	09/12/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/10/2018: Publication reference added.