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NCT07513051
DIaphragmatic Swing According to Cpap Flow Output in NEOnates (DISCONEO)
Conditions: Neonatal Respiratory Distress
Sex: All
Ages: 72 Hours – 10 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Centre Hospitalier Intercommunal Creteil
Location: Centre Hospitalier Intercommunal de Créteil Créteil
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.
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
Source: ClinicalTrials.gov (NCT07513051). StuddyBuddy aggregates publicly available trial information.