NCT07513051

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 72 Hours – 10 Weeks
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Neonatal Respiratory Distress

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-05-02
• Completion: 2027-11-02
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: France