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
Secondary identifying numbers 10146
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

Study designRandomised; Interventional; Design type: Not specified
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 acronymEXTUBATE
Study objectivesBabies 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(s)North West 11 Research ethics committee, Preston approved on 4th Jan 2011, 10/H1016/145
Health condition(s) or problem(s) studiedTopic: 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
InterventionBiPAP: 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 typeOther
Primary outcome measureExtubation Failure; Timepoint(s): This will be defined as: Uncompensated respiratory acidosis defined as pH less than 7.2
Secondary outcome measures1. 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 study start date01/04/2011
Completion date31/03/2014

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participantsPlanned Sample Size: 540; UK Sample Size: 540;
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2011
Date of final enrolment31/03/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Mary's Hospital
Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Trust (CMFT) (UK)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/00he80998

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

08/10/2018: Publication reference added.