Extremely Low Birthweight InfantVolemNCT06334523

Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

A study testing Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI) in people with Extremely Low Birthweight Infant and Continuous Tracheal Gas Insufflation, run by Centre Hospitalier Intercommunal Creteil at 4 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages Up to 7 days
Conditions the study is for: Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation, Medical Device
What is being tested?: Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 4 sitesFrance
Study dates: 13 Feb 2025to 3 Apr 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 7 days
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Claude Danan, M.D. contact

+33609187562

claude.danan@chicreteil.fr

Camille Jung, MD, PhD contact

+33157022268

camille.jung@chicreteil.fr

France4 sites

Centre Hospitalier Intercommunal de Creteil
Créteil, 94010
Fabrice Decobert, MD, +33, fabrice.decobert@chicreteil.fr
laurence caeymaex, MD PhD, +33664095607, laurence.caeymaex@gmail.com
Centre Hospitalier Universitaire de Nantes
Nantes, 44000
Cyril Flamant, MD PhD, +33240083483, cyril.flamant@chu-nantes.fr
Geraldine Apprioual, MD, +33240083483, geraldine.apprioual@chu-nantes.fr
Centre Hopistalier Universitaire Cochin Port Royal aphp
Paris, 75014
Juliana Patkai, MD, +33158413645, juliana.patkai@aphp.fr
Juliana Patkai, MD
Centre hospitalier Robert Debré aphp
Paris, 75019
Valerie Biran, MD PhD, +33140034191, valerie.biran@aphp.fr
Nizar Khattat, MD, +33140031331, nizar.khattat@aphp.fr

Other trials in France

About this study

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

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.

Conditions: Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation, Medical Device, Lung Protection, Ventilator-Induced Lung Injury
Being tested: Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
Keywords: lung protection, extremely low birthweight infant, Ventilator-Induced Lung Injury, mechanical ventilation
Medical subject headings: Ventilator-Induced Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)Device
Also called 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.

Study groups in NCT06334523
Study group	Role	What they receive
Continuous Tracheal Gas Insufflation	Experimental	the preterm infant intubated and ventilated with Continuous Tracheal Gas Insufflation Receives: Device: Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
Standard ventilation without CTGI	No intervention	In the No Intervention arm, the preterm infants are mechanically ventilated using standard ventilation, without the CTGI-device. There is no dead space washout.

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative duration of all periods of non-invasive ventilation
The cumulative duration of all periods of non-invasive ventilation, in days, starting from birth, and up to maximum 45 weeks corrected gestational age. Non-invasive ventilation includes all types of positive pressure support non-invasive ventilation and high flow nasal cannula ventilation (HFNC).
Measured: From birth to the end of hospital stay, up to maximum 45 weeks of corrected gestational age.

Secondary outcomes (32)

Number of participants deceased
For each arm: mortality rate during initial hospitalization.
Measured: 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
Mean Driving pressure (∆P: Ppeak-PEEP) collected each 12 hours for all patients on invasive mechanical ventilation.
Measured: 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.
Mean expiratory tidal volume (VT) collected each 12 hours for all patients on invasive mechanical ventilation.
Measured: 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
Carbon dioxide partial pressure (PCO2) on patient's blood gas during mechanical ventilation
Measured: From enrollment up to maximum 15 days of life
Measure of Transcutaneous Carbon dioxide partial pressure (TcPCO2)
Transcutaneous measure of Carbon dioxide partial pressure (TcPCO2) collected each 12 hours during mechanical ventilation.
Measured: 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
Rates of patients with more than one dose of surfactant replacement therapy.
Measured: From birth up to maximum 7 days of life.
Number of participants treated with high-frequency ventilation (HFV) or high-frequency oscillatory ventilation (HFOV).
Rates of patients treated with High Frequency ventilation (HFV) or High frequency oscillatory ventilation (HFOV) during invasive mechanical ventilation.
Measured: 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)
Rates of patients treated with nitric oxyde (iNO) during invasive mechanical ventilation.
Measured: 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
Rates of patients with Oxygenation Index ≥ 10
Measured: 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
Rates of patients with treated Pneumothorax (Needle Thoracentesis or Chest Drainage)
Measured: 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)
Rates of patients treated with systemic corticosteroids for the prevention or management of BPD and number of days of treatment, excluding prophylactic hydrocortisone treatment in the first 10 days of life.
Measured: 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)
Rates of patients with Bronchopulmonary Dysplasia (BPD) diagnosed at 36 weeks of corrected gestational age.
Measured: From two days before 36 weeks of corrected gestational age until two days after 36 weeks of corrected gestational age..
Number of participants with unplanned extubation
Rates of unplanned extubations per 100 ventilator days, and context.
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Calculation of days with invasive mechanical ventilation for each participant.
Number of days spent on invasive mechanical ventilation
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Calculation of the mean age at definitive weaning from invasive ventilation for the participants in each arm.
Age at total weaning from invasive mechanical ventilation
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Age of participants at definitive weaning from all positive pressure ventilatory support
The age in days when the infant is definitively weaned from invasive and non-invasive positive pressure ventilation, excluding High Flow Nasal Canula (HFNC) and Low Flow Nasal Canula ventilation (LFNC).
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Age of the participants at the definitive withdrawal of any Ventilatory Support
The age in days when the infant is definitively weaned from invasive and non-invasive ventilation, including High-Flow Nasal Cannula (HFNC). This excludes Low-Flow Nasal Cannula (LFNC), with or without supplemental oxygen delivery.
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Age of the participants at definitive O2 weaning.
The age in days when the patient is definitively weaned from oxygen supplementation. This includes being weaned from any respiratory support system, as well as from Low-Flow Nasal Cannula, with or without supplemental oxygen delivery.
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of participants with Late-onset primary bloodstream infections
Rates of Late-onset primary bloodstream infections using CDC surveillance definitions, calculated for 1000 central-line days.
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of participants with Neuroimaging complications
Rates of acquired neuroimaging complications: Periventicular Leucomalacia, Cerebellar haemorrhage, Intra-Ventricular Haemorrhage Grade 3 and 4.
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of participants Treated for Retinopathy (ROP)
Rates of Retinopathy (ROP) receiving either retinal laser or intravitreal anti-VEGF therapy.
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of days for each participant of Exposure to systemic analgesic or sedatives treatments
Number of days with systemic analgesic or sedative treatments.
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
First cytokine dosage in tracheal aspirates.
Mean Cytokines dosage from tracheal aspirates in intubated patients (one unique aspiration). This outcome will be assessed only for patients enrolled in the study and on mechanical ventilation between 24 and 48 hours of life.
Measured: Between 24 hours to 48 hours of life.
Second cytokine dosage in tracheal aspirates.
Mean Cytokines dosage from tracheal aspirates in intubated patients (one unique aspiration). This outcomes will be assessed only for patients enrolled in the study and on mechanical ventilation between day 4 and 5 of life.
Measured: Between day 4 to day 5 of life.
Third cytokine dosage in tracheal aspirates.
Mean Cytokines dosage from tracheal aspirates in intubated patients. This outcomes will be assessed only for patients enrolled in the study and on mechanical ventilation between day 10 and day 12 of life.
Measured: Between day 10 to day 12 of life.
Number of participants requiring hemodynamic support.
Rates of patients receiving hemodynamic support during their hospital stay (systemic catecholamines, volume expansion).
Measured: From enrollment in the study to the date of the end of the hospital stay, up to maximum 5 months of life
Measurement of average weight gain for all study participants in each arm.
Weight gain in grams between birth weight and weight at 36 weeks of corrected gestational age.
Measured: From birth to the date of 36 weeks of corrected gestational age.
Number of days for each participant in the study with central venous line
Addition of all the periods the patients has a central line, in days.
Measured: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Resuts of Neurodevelopmental Follow-up for surviving participants.
Results of the validated French version of the "Ages \& stages questionnaires" (ASQ3), a developmental screening tool based on parental reporting for their child. This tool will be sent to the parents, and collected.
Measured: At 2 years of corrected age (± 2 months)
Number of participants with Cerebral Palsy
Rates of patients with cerebral palsy.
Measured: At 2 years of corrected age (± 2 months)
Number of participants with visual disorders at 2 years of age
Rates of patients with severe visual disorders defined as a need for glasses at 2 years of corrected age (± 2 months)
Measured: At 2 years of corrected age (± 2 months)
Number of participants necessitating respiratory drugs during the two first years of life.
Rates of patients with respiratory symptoms in the first two years, defined as the need for respiratory medications (inhaled or systemic) at any time in this period.
Measured: From the date of discharge from the hospital to 2 years of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 20253 Apr 2029

First posted28 Mar 2024
Study start13 Feb 2025 (estimated)
Primary completion2 Apr 2027 (estimated)
Study completion3 Apr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Extremely Low Birthweight InfantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 144 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06334523
Sponsor's protocol ID: Volem
Acronym: Volem
Status last verified: Feb 2025
First submitted: 18 Mar 2024
Last updated: 5 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

Claude Danan, M.D.

+33609187562

claude.danan@chicreteil.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Extremely Low Birthweight Infant trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Randomised Study of Conventional Ventilation Optimised by Dead Space Washout in Extremely Premature Infants
ClinicalTrials.gov ID: NCT06334523
Acronym / sponsor ID: Volem / Volem
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
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 144 participants (estimated)
Lead sponsor: Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
Study start: 13 Feb 2025 (estimated)
Primary completion: 2 Apr 2027 (estimated)
Study completion: 3 Apr 2029 (estimated)
First posted: 28 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Continuous Tracheal Gas Insufflation	Experimental	Device: Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)the preterm infant intubated and ventilated with Continuous Tracheal Gas Insufflation
Standard ventilation without CTGI	No intervention	–In the No Intervention arm, the preterm infants are mechanically ventilated using standard ventilation, without the CTGI-device. There is no dead space washout.

Who may qualify

Ages: Up to 7 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)Also: Continuous Tracheal Gas Insufflation, CTGIThe 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.	Device	Continuous Tracheal Gas Insufflation

Primary outcome

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.
The cumulative duration of all periods of non-invasive ventilation, in days, starting from birth, and up to maximum 45 weeks corrected gestational age. Non-invasive ventilation includes all types of positive pressure support non-invasive ventilation and high flow nasal cannula ventilation (HFNC).

32 secondary outcomes

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..
Number of participants with unplanned extubation
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Calculation of days with invasive mechanical ventilation for each participant.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Calculation of the mean age at definitive weaning from invasive ventilation for the participants in each arm.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Age of participants at definitive weaning from all positive pressure ventilatory support
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Age of the participants at the definitive withdrawal of any Ventilatory Support
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Age of the participants at definitive O2 weaning.
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of participants with Late-onset primary bloodstream infections
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of participants with Neuroimaging complications
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of participants Treated for Retinopathy (ROP)
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Number of days for each participant of Exposure to systemic analgesic or sedatives treatments
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
First cytokine dosage in tracheal aspirates.
Time frame: Between 24 hours to 48 hours of life.
Second cytokine dosage in tracheal aspirates.
Time frame: Between day 4 to day 5 of life.
Third cytokine dosage in tracheal aspirates.
Time frame: Between day 10 to day 12 of life.
Number of participants requiring hemodynamic support.
Time frame: From enrollment in the study to the date of the end of the hospital stay, up to maximum 5 months of life
Measurement of average weight gain for all study participants in each arm.
Time frame: From birth to the date of 36 weeks of corrected gestational age.
Number of days for each participant in the study with central venous line
Time frame: From birth to the date of the end of the hospital stay, up to maximum 5 months of life
Resuts of Neurodevelopmental Follow-up for surviving participants.
Time frame: At 2 years of corrected age (± 2 months)
Number of participants with Cerebral Palsy
Time frame: At 2 years of corrected age (± 2 months)
Number of participants with visual disorders at 2 years of age
Time frame: At 2 years of corrected age (± 2 months)
Number of participants necessitating respiratory drugs during the two first years of life.
Time frame: From the date of discharge from the hospital to 2 years of age

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Individual participant dataSharing planned: No

Related trials for Extremely Low Birthweight Infant

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Claude Danan, M.D. contact

+33609187562

claude.danan@chicreteil.fr

Camille Jung, MD, PhD contact

+33157022268

camille.jung@chicreteil.fr

Juliana PATKAI, MD principal investigator

CHU Cochin-Port Royal

Valérie BIRAN, MD, PhD principal investigator

CHU Robert Debré

Cyril FLAMANT, MD, PhD principal investigator

Nantes University Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claude Danan, M.D. (+33609187562, claude.danan@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06334523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.