Clinical trial NCT06334523: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Extremely Low Birthweight Infant
Continuous Tracheal Gas Insufflation
Medical Device
Lung Protection
Ventilator-Induced Lung Injury
Keywords: lung protection
extremely low birthweight infant
Ventilator-Induced Lung Injury
mechanical ventilation
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 144
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Cumulative duration of all periods of non-invasive ventilation
timeFrame: From birth to the end of hospital stay, up to maximum 45 weeks of corrected gestational age.
Secondary outcomes:
measure: Number of participants deceased
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Measure of the Driving Pressure during mechanical ventilation
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Measure of expiratory tidal volume during mechanical ventilation.
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Measure of carbon dioxide partial pressure (PCO2) on blood gas
timeFrame: From enrollment up to maximum 15 days of life
measure: Measure of Transcutaneous Carbon dioxide partial pressure (TcPCO2)
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of participants who received a second dose of surfactant
timeFrame: From birth up to maximum 7 days of life.
measure: Number of participants treated with high-frequency ventilation (HFV) or high-frequency oscillatory ventilation (HFOV).
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Use of Inhaled Nitric Oxide (iNO therapy)
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of participant with Severe hypoxemia
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of participants treated for Pneumothorax
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of participants treated with Systemic Corticosteroids for Prevention or Management of Bronchopulmonary Dysplasia (BPD)
timeFrame: From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of participants diagnosed as Bronchopulmonary Dysplasia (BPD)
timeFrame: From two days before 36 weeks of corrected gestational age until two days after 36 weeks of corrected gestational age..
measure: Number of participants with unplanned extubation
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Calculation of days with invasive mechanical ventilation for each participant.
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Calculation of the mean age at definitive weaning from invasive ventilation for the participants in each arm.
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Age of participants at definitive weaning from all positive pressure ventilatory support
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Age of the participants at the definitive withdrawal of any Ventilatory Support
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Age of the participants at definitive O2 weaning.
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of participants with Late-onset primary bloodstream infections
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of participants with Neuroimaging complications
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of participants Treated for Retinopathy (ROP)
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Number of days for each participant of Exposure to systemic analgesic or sedatives treatments
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: First cytokine dosage in tracheal aspirates.
timeFrame: Between 24 hours to 48 hours of life.
measure: Second cytokine dosage in tracheal aspirates.
timeFrame: Between day 4 to day 5 of life.
measure: Third cytokine dosage in tracheal aspirates.
timeFrame: Between day 10 to day 12 of life.
measure: Number of participants requiring hemodynamic support.
timeFrame: From enrollment in the study to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Measurement of average weight gain for all study participants in each arm.
timeFrame: From birth to the date of 36 weeks of corrected gestational age.
measure: Number of days for each participant in the study with central venous line
timeFrame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
measure: Resuts of Neurodevelopmental Follow-up for surviving participants.
timeFrame: At 2 years of corrected age (± 2 months)
measure: Number of participants with Cerebral Palsy
timeFrame: At 2 years of corrected age (± 2 months)
measure: Number of participants with visual disorders at 2 years of age
timeFrame: At 2 years of corrected age (± 2 months)
measure: Number of participants necessitating respiratory drugs during the two first years of life.
timeFrame: From the date of discharge from the hospital to 2 years of age
Other outcomes:
Locations:
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Centre Hopistalier Universitaire Cochin Port Royal aphp
city: Paris
country: France
facility: Centre hospitalier Robert Debré aphp
Study officials:
affiliation: CHU Cochin-Port Royal
name: Juliana PATKAI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Robert Debré
name: Valérie BIRAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Cyril FLAMANT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHI de Créteil
name: Fabrice DECOBERT, MD
role: PRINCIPAL_INVESTIGATOR
References: