Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout (Volem)

Open Randomized Study of Conventional Ventilation Optimized by Dead Space Washout in Extremely Premature Infants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilator-Induced Lung Injury; Medical Device; Extremely Low Birthweight Infant; Continuous Tracheal Gas Insufflation; Lung Protection
• Intervention / Treatment: Device: ventilation

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Camille JUNG; Phone Number: 0157022268; Email: camille.jung@chicreteil.fr
• Study Contact Backup: Name: Claude Danan; Phone Number: 0157022268; Email: claude.Danan@chicreteil.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Term between 23sa + 0j to 26sa + 6j
• Age 7 days
• Research associated DMs available
• beneficiary of a social security scheme

Exclusion Criteria:

• Carrier of a malformation that can alter the prognosis
• Carrier of a grade >2 intraventricular hemorrhage or other abnormality
• brain that can alter prognosis.
• Carrier of a genetic abnormality that can alter the prognosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Tracheal Gas Insufflation; the preterm infant intubated and ventilated with Continuous Tracheal Gas Insufflation	Device: ventilation; the premature infant will be ventillad by respirator and medical device "S-lem" for reduce the Continuous Tracheal Gas Insufflation (CTGI). The CTGI is a ventilation option conventional to reduce or even cancel space anatomical death due to respiratory prostheseses.; Other Names: Continuous Tracheal Gas Insufflation
No Intervention: standar ventilation; the preterm infant intubated and ventilated by standard ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative duration of non-invasive ventilation periods in living patients	It is measured in number of days until the end of 45 gestation week or until the definitive withdrawal of any ventilatory support in positive pressure if it intervenes before 45 gestation week	45 weeks of corrected gestational age.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pressure gradient of the ventilation	Pressure gradient level in invasive ventilation	up to 24 weeks
The age at the definitive withdrawal of any ventilatory support (PPS)	Age at definitive withdrawal from invasive ventilation	"up to 36 weeks of corrected gestational age
Definitive weaning age of invasive ventilation	age at total weaning from any ventilatory support	"up to 36 weeks of corrected gestational age
Definitive O2 weaning age	age at total weaning from oxygen	at the end of the intervention/procedure/surgery"
the death rate	the death rate	"through study completion
The rate of recourse to the HFO	Frequency of HFO (High Frequency Oscillation)	"up to 36 weeks of corrected gestational age
The level of pneumothorax	Pneumothorax frequency	through study completion
The rate of bronchopulmonary dysplasia (BPD) diagnosed	The rate of bronchopulmonary dysplasia (BPD) diagnosed	36 week of gestational age via the Walsh test
Rate of postnatal systemic corticosteroid therapy	Rate of postnatal systemic corticosteroid therap	through study completion
Duration of exposure to systemic sedatives	cumulative day with systemic sedative prescription	through study completion
The cumulative day invasive ventilation	The cumulative day invasive ventilation	"up to 36 weeks of corrected gestational age
Non-programmed extubation rate	Frequency of unscheduled extubations	"up to 36 weeks of corrected gestational age
Rate of secondary blooddstream infection	Rate of secondary blooddstream infection	through study completion
neuroimaging complication	description of neuroimaging complication	through study completion
Neurodevelopmental monitoring	Ages and stages questionnaires, ASQ test	at 2 years of age
Pulmonary inflammation by cytokine dosage for intubated patients	cytokines dosage	between 24 hours to 48 hours of inclusion
Pulmonary inflammation by cytokine dosage for intubated patients	cytokines dosage	between day 4 to day 5 of inclusion
Pulmonary inflammation by cytokine dosage for intubated patients	cytokines dosage	between day 10 to day 12 of inclusion
rate of Retinopathy rank >1	rate of Retinopathy rank >1	through study completion
severe hypoxemia	number of patient with oxygenation index ≥ 10	"up to 36 weeks of corrected gestational age
Additional dose of surfactant	number of patient with an additional dose of surfactant	"up to 36 weeks of corrected gestational age

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: Juliana PATKAI, CHU Cochin; Principal Investigator: Valérie BIRAN, CHU Robert Debré; Principal Investigator: Cyril FLAMANT, Nantes University Hospital; Principal Investigator: Fabrice Dr DECOBERT, CHI de Créteil

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ventilator-Induced Lung Injury; lung protection; extremely low birthweight infant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Body Weight; Thoracic Injuries; Birth Weight; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: Volem

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No