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Recruiting NCT07513051

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

No phase Interventional Neonatal Respiratory Distress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP, VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP, CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP, VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP.
Who it may be relevant to
Registry conditions: Neonatal Respiratory Distress. Basic parameters: 72 Hours — 10 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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).

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • COMFORTneo score [Time frame: 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]
  • 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]
  • 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]
  • SPO2 (%) [Time frame: 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]
  • 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]]
  • 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]
  • 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]
  • 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]
  • FiO2 (%) [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Centre Hospitalier Intercommunal de Créteil — Créteil

Identifiers

NCT: NCT07513051 · DISCONEO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗