Post-extubation Pressures in Preterm Neonates: A CER Study

Sponsor
McMaster Children's Hospital
Study ID
NCT06552455
Status
Not Yet Recruiting

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Conditions

  • Bronchopulmonary Dysplasia
  • Preterm Birth
  • Respiratory Distress Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 14, 2024
Start date
Nov 1, 2024
Status verified
Aug 2024
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,050 participants (estimated)

Arms

  • Arm: Higher Pressure
    Use of initial post-extubation pressures that are 2 cmH2O higher than the pre-extubation measured mean airway pressure (Paw). This can be via either CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation). Higher CPAP: Initial set Paw level on CPAP = Pre-extubation measured Paw level + 2 cmH2O Higher NIPPV: Initial set Paw level on NIPPV = Pre-extubation measured Paw level + 2 cmH2O
  • Arm: Equal/Lower Pressure
    Use of initial post-extubation pressures that is equal to/lower than the pre-extubation measured mean airway pressure (Paw). This can be via either CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation). Equal/Lower CPAP: Initial set Paw level on CPAP ≤ Pre-extubation measured Paw level Equal/Lower NIPPV: Initial set Paw level on NIPPV ≤ Pre-extubation measured Paw level

Primary Outcome Measure

Re-intubation within 7 days post-extubation [ Time Frame: 7 days ]

Central Contacts

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