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Neonatal Respiratory DistressNCT07513051

DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)

A study testing CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP, VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP and CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP in people with Neonatal Respiratory Distress, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The hypothesis behind the study is that the performance of constant flow CPAP (Continuous Positive Airway Pressure) devices (CF-CPAP) is not inferior to that of variable flow CPAP devices (VF-CPAP) in terms of respiratory efforts assessed by swing EAdi (Electrical activity of diaphragm) in a population of premature… Read more about this study

Who is it for?
Ages 72 hours to 10 weeks
Conditions the study is for
Neonatal Respiratory Distress
What is being tested?
CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP, VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP and CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteFrance
Study dates
10 Jun 2026to 12 Dec 2027
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 72 hours to 10 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Neonates born at ≤ 32 weeks GA (gestational age)
  • Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit)
  • Receiving CPAP since > 24 hours at inclusion
  • Equipped with EAdi catheters.
  • Aged more than 72 hours
  • With parental consent
Show all 16Show fewer
  • Affiliated to or benefiting from a social security system
  • Non inclusion Criteria:
  • More than 1 episode of apnea / hour and/or hypercapnic acidosis (defined as pH < 7.20 and/or pCO2 > 65)
  • FiO2 > 60%
  • Neonatal ARDS (acute respiratory distress syndrome) according to the Montreux definition
  • Pneumothorax/ pneumomediastinum
  • Nasal lesions contraindicating nasal noninvasive ventilation
  • Major congenital malformation/Chromosomopathies
  • Congenital neuromuscular diseases
  • Hemodynamic instability

Who cannot join

None listed.

Trial locations and contacts

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

Xavier DURRMEYER, MD, PhD contact

0157023468

Durrmeyer.xavier@chicreteil.fr

Anatole DECAIX, MD contact

Anatole.decaix@chicreteil.fr

France1 site, 1 recruiting

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000

    Xavier DURRMEYER, MD, PhD, 0157023468, xavier.durrmeyer@chicreteil.fr

    Anatole DECAIX, MD, Anatole.decaix@chicreteil.fr

    Recruiting

Other trials in France

About this study

Official title: Diaphragmatic Activity During Constant or Variable Flow CPAP in Neonates: a Non-inferiority, Randomized, Alternating Treatments Trial

The hypothesis behind the study is that the performance of constant flow CPAP (Continuous Positive Airway Pressure) devices (CF-CPAP) is not inferior to that of variable flow CPAP devices (VF-CPAP) in terms of respiratory efforts assessed by swing EAdi (Electrical activity of diaphragm) in a population of premature neonates born ≤ 32 weeks of gestational age.

Read the detailed description

CPAP is an indispensable tool in NICU (neonatal intensive care unit ) to recruit and maintain lung volume, to reduce airway resistances and increase pulmonary compliance. However, the variety of existing pressure generators (constant-flow=CF-CPAP or variable flow=VF-CPAP) and interfaces (prongs, masks) makes evidence-based clinical decisions difficult. Considering the persisting controversy regarding the comparative efficacy of CF-CPAP versus VF-CPAP, new less- or non-invasive tools such diaphragmatic electrical activity (EAdi) monitoring may allow to better evaluate their impact on respiratory efforts.

Our hypothesis is that CF-CPAP devices with nasal mask are not inferior to VF-CPAP devices with nasal mask regarding respiratory efforts assessed by observed swing EAdi in a population of neonates born at ≤ 32 weeks gestational age.

Being tested
CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP, VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP, CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP, VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP
Keywords
Continuous Positive Airway Pressure (CPAP), Variable flow Continuous Positive Airway Pressure (VF-CPAP), Constant flow Continuous Positive Airway Pressure (CF-CPAP), Respiratory Effort, Infant comfort, Diaphragmatic electrical activity (EADi)
Medical subject headings
Pulmonary Atelectasis

What participants receive

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

  • CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAPDevice

    On day 1 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

    On day 2 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

  • VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAPDevice

    On day 1 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

    On day 2 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

  • CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAPDevice

    On day 1 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

    On day 2 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

  • VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAPDevice

    On day 1 : 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

    On day 2 : 2 hours of Constant Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording) then 2 hours of Variable Flow CPAP (30 minutes wash out then 1 hour 30 minutes recording).

Study groups in NCT07513051
Study groupRoleWhat they receive
AABB (CF-CPAP; CF-CPAP;VF-CPAP;VF-CPAP)ExperimentalNot described
Receives: Device: CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP
BBAA (VF-CPAP; VF-CPAP;CF-CPAP;CF-CPAP)ExperimentalNot described
Receives: Device: VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP
ABBA (CF-CPAP; VF-CPAP;VF-CPAP;CF-CPAP)ExperimentalNot described
Receives: Device: CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP
BAAB (VF-CPAP; CF-CPAP;CF-CPAP;VF-CPAP)ExperimentalNot described
Receives: Device: VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP

What is being measured

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

  1. Mean swing EAdi (µV)

    EAdi will be recorded during each ventilation period with CF-CPAP or VF-CPAP and the mean swing EAdi will be calculated after a 30 minutes wash-out period for each ventilation period

    Measured: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period

Secondary outcomes (14)

  1. COMFORTneo score

    A higher score indicates higher pain/discomfort

    Scores of COMFORTneo scale :

    • excessive: score <11
    • appropriate: score between 11 to 13
    • insufficient : score >13

    Measured: At the beginning and at the end of each ventilation period, up to 2 hours

  2. Transcutaneous CO2 pressure TcPCO2 (mm Hg)

    Measured: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period

  3. Heart rate beats per minute (bpm)

    Measured: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

  4. Respiratory rate cycles/minute

    Measured: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

  5. SPO2 (%)

    Measured: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

  6. Mean arterial blood pressure (mm Hg)

    Measured: At the beginning and at the end of each ventilation period, up to 2 hours

  7. Mean phasic peak EAdi (µV)

    Measured: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period]

  8. Mean tonic peak EAdi (µV)

    Measured: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period

  9. CPAP level (cm H20)

    Measured: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

  10. CPAP flow if variable flow CPAP (l/min)

    Measured: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

  11. FiO2 (%)

    Measured: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

  12. Number of events of Bradycardia < 100 bpm

    Measured: During each ventilation period, up to 2 hours

  13. Number of events of Desaturation < 80 %

    Measured: During each ventilation period, up to 2 hours

  14. Number of adverse events

    Measured: During each ventilation period, up to 2 hours

Timeline

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

  1. First posted6 Apr 2026
  2. Study start10 Jun 2026
  3. Primary completion12 Jun 2026
  4. Study completion12 Dec 2027 (estimated)

Resources

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
Crossover
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07513051
Sponsor's protocol ID
DISCONEO
Status last verified
Jun 2026
First submitted
27 Mar 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP, VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP and CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP in people with Neonatal Respiratory Distress, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.

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 16 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Xavier DURRMEYER, MD, PhD (0157023468, Durrmeyer.xavier@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean swing EAdi (µV) (time frame: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period). 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 NCT07513051.

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 23 Jun 2026.

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