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

With prolonged stays in the neonatal intensive care unit (NICU) and significant respiratory morbidity, respiratory management of the most premature newborns - born before 28 weeks gestational age (GA) - brings a number of challenges. Despite recommendations to give priority to non-invasive ventilation in cases of respiratory insufficiency, recent studies show that over 80% of these newborns receive mechanical ventilation (MV) at least once in their NICU course, most within the first week of life (100% if born at 23 SA, \>90% at 24 and 25 SA, \>80% at 26 and \>70% at 27 weeks GA). Several studies have shown that a longer cumulative duration of MV is associated with a worse respiratory and neurodevelopmental prognosis in this population.

Early extubation is therefore recommended. However, extubation failures in patients born at these early stages of life are common and are per se associated with respiratory morbidity. Extubation failure is defined in the literature as reintubation within days of extubation.

A delay of 7 days after extubation has been identified as the time frame for capturing extubations related to respiratory causes. In a French study, using the SEPREVEN cohort for patients born before 27 weeks' GA, extubation failure at 3, 7 and 15 days concerned 25%, 33% and 50% of patients respectively. The decision to extubate a premature patient is a complex one, but contributes in part to the patient's outcome.

Shalish referred to the concept of "extubation readiness dilemma" to indicate the uncertainty surrounding the clinical features associated with successful extubation. Identifying a state for each patient that allows successful extubation, without reintubation in the following days, is most often based on ward routines in which assessments of the infant's respiratory capacity are taken into account. Medical literature doesn't provide recommendations on extubation criteria, and practices differ from one unit to another.

The aim of this study is to provide a detailed description of extubation practices and failures in several NICUs in France, based on a prospective collection of qualitative and mixed data.

• Reported perceived extubation readiness in Extremely Low Gestational Age Neonates (ELGANs) born before 28weeks gestation and mechanically ventilated in a period within the first 15 days of life. [Time frame: These data will be collected in case of Mechanical Ventilation every 48 hours between the Birthday and Day 2 of life and then every morning between Day 2 and Day 15 of life]
• Occurrence of Extubation failure in ELGANs on Mechanical ventilation within the first 15 days of life. [Time frame: These data will be collected in case of Mechanical Ventilation every 48 hours between the Birthday and Day 2 of life and then every morning between Day 2 and Day 15 of life]
• Corrected gestational age on definitive discontinuation of MV, of Positive Pressure Non-Invasive Ventilation (NIV), of High Flow Nasal Cannula (HFNC) ventilation) and Low Flow Nasal Cannula Ventilation (LFNNC) [Time frame: From the day of birth to 4 months of age.]
• Cumulative duration of mechanical ventilation (MV) during the NICU stay. [Time frame: These data will be collected from the day of birth to the day of discharge from the NICU, up to maximum 4 months of age..]
• The cumulative duration of any respiratory support [Time frame: From the day of birth to the day of discharge from the hospital, up to maximum 4 months of age.]
• Duration of Mechanical Ventilation and Positive Pressure Non-Invasive Ventilation [Time frame: From the day of birth to the day of discharge from the hospital, up to 4 months of age]
• Bronchopulmonary dysplasia at 36 weeks corrected Gestational Age [Time frame: At 36 weeks corrected gestational age]
• Mortality [Time frame: From the day of birth to the day of discharge from the hospital, maximum 5 months of age]
• Length of stay in the Neonatal Intensive Care Unit (NICU) [Time frame: From the day of birth to the day of discharge from the NICU, maximum 4 months of life]
• Factors involved in the perception of "too altered respiratory condition to be extubated" [Time frame: From the day of birth to day 15 of life during the period on Mechanical Ventilation]
• Clinician-reported Prognosis of extubation succes [Time frame: From day of birth to day 15 of life during the period on Mechanical Ventilation]
• Description of complications of intubation [Time frame: from the day birth to the day discharge from the NICU, up to maximum 4 months of life]