Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

Official title

Open Randomised Study of Conventional Ventilation Optimised by Dead Space Washout in Extremely Premature Infants

Overview

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.

Interventions

• Device Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
  The 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.

Primary outcome measures

• Cumulative duration of all periods of non-invasive ventilation [Time frame: From birth to the end of hospital stay, up to maximum 45 weeks of corrected gestational age.]

Secondary outcome measures (12)

• Number of participants deceased [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Measure of the Driving Pressure during mechanical ventilation [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Measure of expiratory tidal volume during mechanical ventilation. [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Measure of carbon dioxide partial pressure (PCO2) on blood gas [Time frame: From enrollment up to maximum 15 days of life]
• Measure of Transcutaneous Carbon dioxide partial pressure (TcPCO2) [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Number of participants who received a second dose of surfactant [Time frame: From birth up to maximum 7 days of life.]
• Number of participants treated with high-frequency ventilation (HFV) or high-frequency oscillatory ventilation (HFOV). [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Use of Inhaled Nitric Oxide (iNO therapy) [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Number of participant with Severe hypoxemia [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Number of participants treated for Pneumothorax [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Number of participants treated with Systemic Corticosteroids for Prevention or Management of Bronchopulmonary Dysplasia (BPD) [Time frame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life]
• Number of participants diagnosed as Bronchopulmonary Dysplasia (BPD) [Time frame: From two days before 36 weeks of corrected gestational age until two days after 36 weeks of corrected gestational age..]

Eligibility criteria

Inclusion criteria

• 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
• Beneficiary of a social security system (in France: CMU or securité sociale)
• Parental consent for their infant to participate in this trial

Exclusion criteria

• 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
• Participation in another interventional research trial before inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 4 centers

• Centre Hospitalier Intercommunal de Creteil — Créteil
• Centre Hospitalier Universitaire de Nantes — Nantes
• Centre Hopistalier Universitaire Cochin Port Royal aphp — Paris
• Centre hospitalier Robert Debré aphp — Paris

Identifiers

NCT: NCT06334523 · Volem

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗