Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

Ventilator-Induced Lung Injury Clinical Trial

— Volem  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334523
• Other study ID #: Volem
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Claude Danan
• Phone: 0157022268
• Email: claude.Danan[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: December 31, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 26 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Lung Injury
• Medical Device
• Ventilator-Induced Lung Injury

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Outcome

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