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NCT Number: NCT07513051

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

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.

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Key information

Age range

72 hour–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Above mentioned age limits (72 hours to 10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks).

Inclusion criteria

  • 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
  • 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

Treatment and study plan

CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP

Device

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-CPAP

Device

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-CPAP

Device

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-CPAP

Device

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).

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. COMFORTneo score

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

    A higher score indicates higher pain/discomfort

    Scores of COMFORTneo scale :

    • excessive: score <11
    • appropriate: score between 11 to 13
    • insufficient : score >13
  2. Transcutaneous CO2 pressure TcPCO2 (mm Hg)

    Time frame: 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)

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

  4. Respiratory rate cycles/minute

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

  5. SPO2 (%)

    Time frame: 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)

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

  7. Mean phasic peak EAdi (µV)

    Time frame: 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)

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

  9. CPAP level (cm H20)

    Time frame: 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)

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

  11. FiO2 (%)

    Time frame: 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

    Time frame: During each ventilation period, up to 2 hours

  13. Number of events of Desaturation < 80 %

    Time frame: During each ventilation period, up to 2 hours

  14. Number of adverse events

    Time frame: During each ventilation period, up to 2 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Anatole DECAIX, MD

CONTACT

[email protected]

Xavier DURRMEYER, MD, PhD

CONTACT

[email protected]

0157023468

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

  • Pr Xavier DURRMEYER

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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