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NOT YET RECRUITING
NCT06552455

Post-extubation Pressures in Preterm Neonates: A CER Study

Sponsor: McMaster Children's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Post-extubation Pressures on Non-invasive Respiratory Support in Preterm Neonates: A Prospective Comparative Effectiveness Research Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1050

Start Date

2024-11-01

Completion Date

2028-12-31

Last Updated

2024-08-14

Healthy Volunteers

Not specified