About this trial
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
This trial does not accept healthy volunteersQualifiers
Gestational age < 28 weeks of gestation
Age at admission to the participating unit <24 hours
Disqualifiers
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
Trial population
Participation in the study is proposed to type 3 neonatal intensive care units in France. Extremely premature newborns born before 28 weeks gestation in the participating units will be included.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Reasons for non-extubation in case of MV in patients born before 28 wks GA in the first 15 days of life,
For each included patient who is intubated and mechanically ventilated during a period within his first 15 days of life, the reasons for non-extubation. These are the reasons reported by the physician by answering a qualitative questionnaire with an open-ended question, and preexistent possible multiple choices.
Secondary outcomes
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.
Reported perceived extubation readiness in ELGANs born before 28weeks gestation and mechanically ventilated in a period within the first 15 days of life, defined as Reasons for extubation and ventilatory and clinical data,
Occurrence of Extubation failure in ELGANs on Mechanical ventilation within the first 15 days of life.
Occurrence of Extubation failure defined as reintubation in the 7 days after an extubation.
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)
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)
Cumulative duration of mechanical ventilation (MV) during the NICU stay.
Sum of the days of mechanical ventilation during the NICU stay, collected prospectively.
Other outcomes
Description of unit practices (mechanical ventilation weaning protocol and/or extubation criteria in standard care)
Description of unit practices (use of a Mechanical Ventilation weaning protocol and/or the use of extubation criteria in standard care)
Sponsors and contacts
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