DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)

NCT07513051 | Not Yet Recruiting

• 1 other identifier: DISCONEO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Continuous Positive Airway Pressure (CPAP); Variable flow Continuous Positive Airway Pressure (VF-CPAP); Constant flow Continuous Positive Airway Pressure (CF-CPAP); Respiratory Effort; Infant comfort; Diaphragmatic electrical activity (EADi)

Outcome Measures

Primary Outcomes (1)

• Mean swing EAdi (µV)

  EAdi will be recorded during each ventilation period with CF-CPAP or VF-CPAP and the mean swing EAdi will be calculated after a 30 minutes wash-out period for each ventilation period

  Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period

Secondary Outcomes (14)

• COMFORTneo score

  At the beginning and at the end of each ventilation period, up to 2 hours

• Transcutaneous CO2 pressure TcPCO2 (mm Hg)

  Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period

• Heart rate beats per minute (bpm)

  Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

• Respiratory rate cycles/minute

  Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

• SPO2 (%)

  Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation

Study Arms (4)

AABB (CF-CPAP; CF-CPAP;VF-CPAP;VF-CPAP)

EXPERIMENTAL

Device: CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP

BBAA (VF-CPAP; VF-CPAP;CF-CPAP;CF-CPAP)

EXPERIMENTAL

Device: VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP

ABBA (CF-CPAP; VF-CPAP;VF-CPAP;CF-CPAP)

EXPERIMENTAL

Device: CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP

BAAB (VF-CPAP; CF-CPAP;CF-CPAP;VF-CPAP)

EXPERIMENTAL

Device: VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP

Interventions

CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP DEVICE

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).

AABB (CF-CPAP; CF-CPAP;VF-CPAP;VF-CPAP)

VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP DEVICE

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).

BBAA (VF-CPAP; VF-CPAP;CF-CPAP;CF-CPAP)

CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP DEVICE

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).

ABBA (CF-CPAP; VF-CPAP;VF-CPAP;CF-CPAP)

VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP DEVICE

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).

BAAB (VF-CPAP; CF-CPAP;CF-CPAP;VF-CPAP)

Eligibility Criteria

• Age: 72 Hours - 10 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates born at ≤ 32 weeks GA (gestational age)
• Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit)
• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Pr Xavier DURRMEYER: collaborator

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xavier DURRMEYER, MD, PhD

CONTACT

0157023468; Durrmeyer.xavier@chicreteil.fr

Anatole DECAIX, MD

CONTACT

Anatole.decaix@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 6, 2026
• Study Start: June 10, 2026
• Primary Completion: June 10, 2026
• Study Completion (Estimated): December 10, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

FR (1)