Study on Extubation Decisions and Outcomes in Extremely Preterm Infants Born Before 28 Weeks Gestation

What this Trial Is About

This research aims to understand how neonatologists decide when extremely preterm infants, born before 28 weeks of gestational age, are ready to be taken off mechanical ventilation during the first two weeks of life. It focuses on the link between clinical assessments of extubation readiness and actual success, defined as no need for reintubation within seven days. The study also seeks to identify factors influencing these decisions and outcomes using both qualitative and quantitative data from several NICUs in France. The study involves no interventions or treatments but collects prospective information from attending physicians through questionnaires completed daily for the first 15 days of life while the infants are mechanically ventilated. Researchers will record reasons for extubation or non-extubation and monitor respiratory outcomes, including extubation failure rates and the duration of various types of respiratory support up to four months of age. Mortality and complications related to intubation will also be documented. Participants will be closely observed throughout their NICU stay, with data collected on respiratory status, mechanical ventilation duration, and clinical decisions regarding extubation. The primary outcome is the reasons for not extubating during the first 15 days of life, assessed multiple times daily early on and daily thereafter. Secondary outcomes include extubation readiness perceptions, extubation failure, bronchopulmonary dysplasia occurrence, length of NICU stay, and mortality up to five months of age. The study will conclude when patients are discharged or definitively weaned off respiratory support.

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