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

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.

NCT Number	NCT06808997
Lead Sponsor	Centre Hospitalier Intercommunal Creteil
Conditions	PreTerm Neonate, Extubation Readiness, Extubation Failure, Respiratory Morbidity, Bronchopulmonary Dysplasia, Mechanical Ventilation
Enrollment	100 participants
Start Date	2025-02-17
Primary Completion	2026-01-05 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-12