DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)
NCT07513051 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-06-23
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.
Conditions
- Neonatal Respiratory Distress
Interventions
- DEVICE
-
CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP
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).
- DEVICE
-
VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP
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).
- DEVICE
-
CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP
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).
- DEVICE
-
VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP
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).
Sponsors & Collaborators
-
Pr Xavier DURRMEYER
collaborator UNKNOWN -
Centre Hospitalier Intercommunal Creteil
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 72 Hours
- Max Age
- 10 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-10
- Primary Completion
- 2026-06-12
- Completion
- 2027-12-12
Countries
- France
Study Locations
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