About this trial
The optimal post-extubation pressure level on non-invasive respiratory support modes - irrespective of the choice of the specific non-invasive mode - that optimizes extubation success and improves clinical outcomes remains unknown.
The investigators aim to determine the optimal initial non-invasive pressure support level post-extubation in preterm neonates, in relation to the pre-extubation measured mean airway pressures (Paw). The hypothesis is that use of higher pressures will lead to fewer re-intubations.
This will be a prospective comparative effectiveness study across participating tertiary NICUs across Canada. Centres will self-select whether to use Higher or Equal/Lower pressure levels as well as the initial post-extubation mode (NIPPV or CPAP) for the study duration. Only the first eligible extubation will be included for analysis. Eligible patients \<28 weeks' gestational age at birth undergoing an eligible extubation (from a mean airway pressure \</= 13 cmH2O) will be included. The primary outcome will be re-intubation within 7 days. Secondary outcomes will include other neonatal morbidities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm neonates GA <28 weeks' gestation, admitted to a participating centre who received any duration of mechanical ventilation.
Disqualifiers
Major chromosomal/genetic/congenital abnormalities
Never received invasive mechanical ventilation (IMV)
Received IMV, but never extubated to non-invasive respiratory support (NRS)
Transferred to non-participating site while intubated
Trial population
As above
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Re-intubation within 7 days post-extubation
Secondary outcomes
Failure of initial NRS (non-invasive respiratory support) mode
Presence of any 1 or more predefined intubation criteria
Moderate to Severe Bronchopulmonary Dysplasia
Mortality
Locations
Sponsors and contacts
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McMaster Children's Hospital
Lead sponsor
McMaster University
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Canadian Neonatal Network
Collaborator
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