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

April 3, 2026 updated by: Centre Hospitalier Intercommunal Creteil

Diaphragmatic Activity During Constant or Variable Flow CPAP in Neonates: a Non-inferiority, Randomized, Alternating Treatments Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Above mentioned age limits (72 hours to 10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks).

Inclusion Criteria:

  • 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

Non inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AABB (CF-CPAP; CF-CPAP;VF-CPAP;VF-CPAP)
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).
Experimental: BBAA (VF-CPAP; VF-CPAP;CF-CPAP;CF-CPAP)
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).
Experimental: ABBA (CF-CPAP; VF-CPAP;VF-CPAP;CF-CPAP)
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).
Experimental: BAAB (VF-CPAP; CF-CPAP;CF-CPAP;VF-CPAP)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean swing EAdi (µV)
Time Frame: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
COMFORTneo score
Time Frame: At the beginning and at the end of each ventilation period, up to 2 hours

A higher score indicates higher pain/discomfort

Scores of COMFORTneo scale :

  • excessive: score <11
  • appropriate: score between 11 to 13
  • insufficient : score >13
At the beginning and at the end of each ventilation period, up to 2 hours
Transcutaneous CO2 pressure TcPCO2 (mm Hg)
Time Frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period
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)
Time Frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Respiratory rate cycles/minute
Time Frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
SPO2 (%)
Time Frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Mean arterial blood pressure (mm Hg)
Time Frame: At the beginning and at the end of each ventilation period, up to 2 hours
At the beginning and at the end of each ventilation period, up to 2 hours
Mean phasic peak EAdi (µV)
Time Frame: Continuous recording during 1 hour and 30 minutes 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]
Mean tonic peak EAdi (µV)
Time Frame: Continuous recording during 1 hour and 30 minutes 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
CPAP level (cm H20)
Time Frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
CPAP flow if variable flow CPAP (l/min)
Time Frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
FiO2 (%)
Time Frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Number of events of Bradycardia < 100 bpm
Time Frame: During each ventilation period, up to 2 hours
During each ventilation period, up to 2 hours
Number of events of Desaturation < 80 %
Time Frame: During each ventilation period, up to 2 hours
During each ventilation period, up to 2 hours
Number of adverse events
Time Frame: During each ventilation period, up to 2 hours
During each ventilation period, up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Collaborators

Pr Xavier DURRMEYER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 2, 2026

Study Completion (Estimated)

November 2, 2027

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISCONEO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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