RecruitingNot ApplicableNCT07513051

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

Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

20 participants

Start Date

Jun 10, 2026

Study Type

INTERVENTIONAL

Conditions

Neonatal respiratory distress

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

Min Age: 72 HoursMax Age: 10 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP, a medical device called CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP, and others for people with neonatal respiratory distress. The study is currently recruiting participants at 1 location. People eligible for this study include aged 72 Hours to 10 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECF-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).

DEVICEVF-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).

DEVICECF-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).

DEVICEVF-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).

Locations(1)

Centre Hospitalier Intercommunal de Créteil

Créteil, France

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NCT07513051

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