protocolSection identificationModule nctId: NCT06334523, orgStudyIdInfo id: Volem, briefTitle: Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout, acronym: Volem, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Intercommunal Creteil, class: OTHER, descriptionModule briefSummary: The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional ventilation to reduce or even cancel dead space due to respiratory prostheses. This objective is particularly interesting in the smallest preterm infants in which 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/min at tip of endotracheal tube to purge expired CO2 trapped in the prostheses to have a CO2-free volume of gas available for subsequent insufflation., conditionsModule conditions: Extremely Low Birthweight Infant, conditions: Continuous Tracheal Gas Insufflation, conditions: Medical Device, conditions: Lung Protection, conditions: Ventilator-Induced Lung Injury, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: ventilation, outcomesModule primaryOutcomes measure: cumulative duration of non-invasive ventilation periods in living patients, secondaryOutcomes measure: The pressure gradient of the ventilation, secondaryOutcomes measure: The age at the definitive withdrawal of any ventilatory support (PPS), secondaryOutcomes measure: Definitive weaning age of invasive ventilation, secondaryOutcomes measure: Definitive O2 weaning age, secondaryOutcomes measure: the death rate, secondaryOutcomes measure: The rate of recourse to the HFO, secondaryOutcomes measure: The level of pneumothorax, secondaryOutcomes measure: The rate of bronchopulmonary dysplasia (BPD) diagnosed, secondaryOutcomes measure: Rate of postnatal systemic corticosteroid therapy, secondaryOutcomes measure: Duration of exposure to systemic sedatives, secondaryOutcomes measure: The cumulative day invasive ventilation, secondaryOutcomes measure: Non-programmed extubation rate, secondaryOutcomes measure: Rate of secondary blooddstream infection, secondaryOutcomes measure: neuroimaging complication, secondaryOutcomes measure: Neurodevelopmental monitoring, secondaryOutcomes measure: Pulmonary inflammation by cytokine dosage for intubated patients, secondaryOutcomes measure: Pulmonary inflammation by cytokine dosage for intubated patients, secondaryOutcomes measure: Pulmonary inflammation by cytokine dosage for intubated patients, secondaryOutcomes measure: rate of Retinopathy rank >1, secondaryOutcomes measure: severe hypoxemia, secondaryOutcomes measure: Additional dose of surfactant, eligibilityModule sex: ALL, minimumAge: 23 Weeks, maximumAge: 26 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False