Post-extubation Pressures in Preterm Neonates: A CER Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMcMaster Children's Hospital

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,050 Participants
are grouped into 2 trial groups
Group A: Higher Pressure
Group B: Equal/Lower Pressure

Trial outcomes

Primary outcomes

1

Re-intubation within 7 days post-extubation

Time frame
7 days

Secondary outcomes

1

Failure of initial NRS (non-invasive respiratory support) mode

Time frame
7 days
2

Presence of any 1 or more predefined intubation criteria

Time frame
7 days
3

Moderate to Severe Bronchopulmonary Dysplasia

Time frame
until 36 weeks' postmenstrual age (or discharge if sooner)
4

Mortality

Time frame
During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age)

Other outcomes

Locations

This trial has no 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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