The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses. This objective is of particular interest in the smallest preterm infants, where the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L/minute at the tip of the endotracheal tube to purge expired CO2 trapped in the prostheses, to have a CO2-free volume of gas available for subsequent insufflation.
The goal of this clinical trial is to learn if Continuous Tracheal Gas Insufflation (CTGI) works to reduce ventilatory dependence in preterm infants after mechanical ventilation. It will also learn about the safety of CTGI. The main questions it aims to answer are:
* Does Continuous Tracheal Gas Insufflation (CTGI) reduce the number of days of non-invasive ventilation in extremely preterm infants who needed mechanical ventilation? * Does Continuous Tracheal Gas Insufflation (CTGI) reduce the age at the weaning of any ventilatory support and/or oxygen supplementation.
Researchers will compare the clinical outcome of patients mechanically ventilated with the CTGI-device to the outcome of patients ventilated without the CTGI device, to see if the CTGI ventilation works to reduce ventilation dependence.
Participants will:
• Be mechanically ventilated using CTGI (if randomly assigned in the CTGI-group), for the entire endotracheal ventilation period during their stay in the neonatal intensive care unit.
Gestational Age at birth between 23 weeks gestation + 0 days and 26 weeks gestation + 6days
Age between 0 and 7 days of life
Need for intubation and mechanical ventilation before day 8 of life
Availability of the Research-associated medical devices
Known Severe Congenital Malformation (potential life-threatening malformation)
Known Preexisting Severe Intraventricular Haemorrhage (grade 3 or 4) and/or other brain abnormality that can alter life prognosis
Known Genetic Disorder (potential life-threatening malformation)
Preexistent mechanical ventilation for a duration of more than 12 hours
Parallel
Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
DeviceThe intervention involves adding a device which allows CTGI (the "CTGI-device") to washout the dead space in preterm mechanically ventilated infants. Dead space washout using the CTGI-device is an option added to standard ventilation, to reduce or even cancel anatomical dead space due to respiratory prostheses in intubated preterm infants.
Cumulative duration of all periods of non-invasive ventilation
The cumulative duration of all periods of non-invasive ventilation, in days, starting from birth, and up to maximum 45 weeks corrected gestational age. Non-invasive ventilation includes all types of positive pressure support non-invasive ventilation and high flow nasal cannula ventilation (HFNC).
Number of participants deceased
For each arm: mortality rate during initial hospitalization.
Measure of the Driving Pressure during mechanical ventilation
Mean Driving pressure (∆P: Ppeak-PEEP) collected each 12 hours for all patients on invasive mechanical ventilation.
Measure of expiratory tidal volume during mechanical ventilation.
Mean expiratory tidal volume (VT) collected each 12 hours for all patients on invasive mechanical ventilation.
Measure of carbon dioxide partial pressure (PCO2) on blood gas
Carbon dioxide partial pressure (PCO2) on patient's blood gas during mechanical ventilation
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