DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)
Diaphragmatic Activity During Constant or Variable Flow CPAP in Neonates: a Non-inferiority, Randomized, Alternating Treatments Trial
Centre Hospitalier Intercommunal Creteil
20 participants
Jun 10, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria15
- 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
- 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
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Interventions
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).
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).
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).
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).
Locations(1)
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NCT07513051