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| Name | Class |
|---|---|
| Pr Xavier DURRMEYER | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AABB (CF-CPAP; CF-CPAP;VF-CPAP;VF-CPAP) | Experimental |
| |
| BBAA (VF-CPAP; VF-CPAP;CF-CPAP;CF-CPAP) | Experimental |
| |
| ABBA (CF-CPAP; VF-CPAP;VF-CPAP;CF-CPAP) | Experimental |
| |
| BAAB (VF-CPAP; CF-CPAP;CF-CPAP;VF-CPAP) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 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 | Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period |
| Measure | Description | Time Frame |
|---|---|---|
| COMFORTneo score | A higher score indicates higher pain/discomfort Scores of COMFORTneo scale :
| At the beginning and at the end of each ventilation period, up to 2 hours |
| Transcutaneous CO2 pressure TcPCO2 (mm Hg) |
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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:
Non inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier DURRMEYER, MD, PhD | Contact | 0157023468 | Durrmeyer.xavier@chicreteil.fr | |
| Anatole DECAIX, MD | Contact | Anatole.decaix@chicreteil.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal de Créteil | Recruiting | Créteil | 94000 | France |
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|
| VF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP | Device | 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). |
|
| CF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP | Device | 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). |
|
| VF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP | Device | 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). |
|
| 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) | Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation |
| Respiratory rate cycles/minute | Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation |
| SPO2 (%) | 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) | At the beginning and at the end of each ventilation period, up to 2 hours |
| Mean phasic peak EAdi (µV) | Continuous recording during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period] |
| Mean tonic peak EAdi (µV) | Continuous recording during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period |
| CPAP level (cm H20) | 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) | Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation |
| FiO2 (%) | 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 | During each ventilation period, up to 2 hours |
| Number of events of Desaturation < 80 % | During each ventilation period, up to 2 hours |
| Number of adverse events | During each ventilation period, up to 2 hours |
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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