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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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).
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).
Centre Hospitalier Intercommunal de Créteil
Créteil, France
RECRUITINGMean swing EAdi (µV)
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
Time frame: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period
COMFORTneo score
A higher score indicates higher pain/discomfort Scores of COMFORTneo scale : * excessive: score \<11 * appropriate: score between 11 to 13 * insufficient : score \>13
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]
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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).
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).
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
Number of events of Desaturation < 80 %
Time frame: During each ventilation period, up to 2 hours
Number of adverse events
Time frame: During each ventilation period, up to 2 hours