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