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

RecruitingNAAges 72 Hours - 10 WeeksAllCentre Hospitalier Intercommunal Creteil
NCT07513051 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • 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
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Where

1 site
Centre Hospitalier Intercommunal de Créteil
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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