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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Dr Jean-michel Roue
Brest, Brest, France
COMPLETEDCHU Amiens Sud
Amiens, France
COMPLETEDCH Cote Basque
Bayonne, France
COMPLETEDCHU De Besancon
Besançon, France
COMPLETEDHopital Femme Mére Enfant - HFME
Bron, France
COMPLETEDCentre Hospitalier Public du Cotentin
Cherbourg-Octeville, France
COMPLETEDCH Estaing
Clermont-Ferrand, France
COMPLETEDChu Louis Mourier
Colombes, France
COMPLETEDCHIC
Créteil, France
COMPLETEDCHU Grenoble Alpes _site nord
Grenoble, France
COMPLETED...and 21 more locations
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.
Time frame: On a 12 hours basis from Day 0 to Day 2 of life, and on a dialy basis from Day 2 to Day 15 of life (according to the period the patient is on Mechanical Ventilation)
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,
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.
Occurrence of Extubation failure defined as reintubation in the 7 days after an extubation.
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)
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.
Sum of the days of mechanical ventilation during the NICU stay, collected prospectively.
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
The cumulative duration of positive pressure Non-Invasive Ventilation (PPNIV) and High Flow Nasal Ventilation (HFNV), Low Flow Nasal Ventilation (LFNV) during the entire hospital stay
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
Sum of the days of Mechanical Ventilation or positive pressure non invasive ventilation during the entire hospital stay
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
Bronchopulmonary dysplasia at 36 weeks corrected Gestational age defined as need for any type of ventilation (invasive or non-invasive) or low flow oxygen therapy at 36 weeks gestational age.
Time frame: At 36 weeks corrected gestational age
Mortality
Mortality before discharge from the hospital
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)
Length of stay in the 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"
Description of the reasons related to the respiratory system, clinical respiratory conditions (e;g. apneas ....) and ventilatory settings (pressure, oxygen, ...) reported by the physician associated with a reported "too altered respiratory condition to be extubated" condition.
Time frame: From the day of birth to day 15 of life during the period on Mechanical Ventilation
Clinician-reported Prognosis of extubation succes
Physician-reported prognosis of extubation based on a 4 points scale (from 1 "unconfident" to 4 "very confident")
Time frame: From day of birth to day 15 of life during the period on Mechanical Ventilation
Description of complications of intubation
Description of a multiple choice of complications after each intubation : No complication, oropharyngeal lesion, cardiorespiratory arrest, severe intraventricular haemorraghe, contribution to patient's death.
Time frame: from the day birth to the day discharge from the NICU, up to maximum 4 months of life
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