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

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

Recruiting
72-10 years
All
Phase N/A

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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.

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.

Eligibility

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 details
    Neonatal Respiratory Distress

NCT07513051

Centre Hospitalier Intercommunal Creteil

20 October 2026

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