DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO) (NCT07513051) | Clinical Trial Compass
RecruitingNot Applicable
DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)
France20 participantsStarted 2026-06-10
Plain-language 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 neonates born ≤ 32 weeks of gestational age.
Who can participate
Age range
72 Hours – 10 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean swing EAdi (µV)
Timeframe: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period