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Recruiting NCT06808997

NCT06808997 Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.

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Clinical Trial Summary
NCT ID NCT06808997
Status Recruiting
Phase
Sponsor Centre Hospitalier Intercommunal Creteil
Condition PreTerm Neonate
Study Type OBSERVATIONAL
Enrollment 100 participants
Start Date 2025-02-17
Primary Completion 2026-01-05

Trial Parameters

Condition PreTerm Neonate
Sponsor Centre Hospitalier Intercommunal Creteil
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 1 Minute
Max Age 5 Months
Start Date 2025-02-17
Completion 2026-01-05

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Brief Summary

The purpose of this observational study is to learn about neonatologists' perceptions of extubation readiness and extubation and reintubation practices in extremely preterm infants in the first 2 weeks of life using prospective qualitative and quantitative data. Actual extubation readiness is defined as successful extubation, defined as no reintubation in the 7 days following extubation. Key research questions are: How do clinicians assess extubation readiness in this population? Does this assessment correlate with actual extubation success? What factors (reasons, clinical status, ventilatory parameters) are associated with extubation readiness? Patients born before 28 weeks gestational age and admitted to the neonatal intensive care unit (NICU) within the first 24 hours are be included. The attending physician will complete a prospectively administered questionnaire with open-ended and multiple-choice questions to daily assess the decision and rationale for extubation or non-extubation of patients mechanically ventilated during the first 15 days of life. Patient characteristics, respiratory outcomes, and mortality will be recorded until the end of hospitalisation and/or definitive weaning from any ventilatory support or supplemental oxygen.

Eligibility Criteria

Inclusion Criteria: * Gestational age \< 28 weeks of gestation * Age at admission to the participating unit \<24 hours Exclusion Criteria: * Parental opposition to their infant's clinical data collection * Participation in a research protocol with potential impact on extubation and/or duration of mechanical ventilation

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