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Post-extubation Pressures in Preterm Neonates: A CER Study

NCT06552455 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1050

Last updated 2024-08-14

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome
  • Bronchopulmonary Dysplasia
  • Preterm Birth

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Neonatal Network

    collaborator OTHER

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Amit Mukerji, MD · McMaster University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2028-03-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552455 on ClinicalTrials.gov