Status:
NOT_YET_RECRUITING
Post-extubation Pressures in Preterm Neonates: A CER Study
Lead Sponsor:
McMaster Children's Hospital
Collaborating Sponsors:
McMaster University
Canadian Institutes of Health Research (CIHR)
Conditions:
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Eligibility:
All Genders
Brief 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 cli...
Detailed Description
BACKGROUND Invasive mechanical ventilation (IMV) is a well-established risk factor for bronchopulmonary dysplasia and associated long-term complications. In recent years, a large body of research has ...
Eligibility Criteria
Inclusion
- Preterm neonates GA \<28 weeks' gestation, admitted to a participating centre who received any duration of mechanical ventilation.
Exclusion
- 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
- Death prior to extubation
- Initial extubation was for withdrawal of care
- Lack of any eligible extubation, eligible defined as ALL of the following: (i) ≥36 continuous hours on IMV; (ii) pre-extubation MAP ≤13 cmH2O; and (iii) on post-extubation NRS for ≥1 hour.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT06552455
Start Date
November 1 2024
End Date
December 31 2028
Last Update
August 14 2024
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