Centre Hospitalier Intercommunal de Créteil
Créteil, 94000, France
Location status: Recruiting
Location contact
Anatole DECAIX, MD
CONTACT
Xavier DURRMEYER, MD, PhD
CONTACT
NCT Number: NCT07513051
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.
Interested in participating?
Request Info72 hour–10 week
All sexes
Interventional
Not applicable
Créteil, 94000, France
Location status: Recruiting
Anatole DECAIX, MD
CONTACT
Xavier DURRMEYER, MD, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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).
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).
Time frame: Continuous recording during 1 hour and 30 minutes after a 30 minutes wash-out period for each ventilation period
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: At the beginning and at the end of each ventilation period, up to 2 hours
A higher score indicates higher pain/discomfort
Scores of COMFORTneo scale :
Time frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation period
Time frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Time frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Time frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Time frame: At the beginning and at the end of each ventilation period, up to 2 hours
Time frame: Continuous recording during 1 hour and 30 minutes 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
Time frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Time frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Time frame: Every 30 minutes during 1 hour and 30 minutes after a 30 minutes wash out period for each ventilation
Time frame: During each ventilation period, up to 2 hours
Time frame: During each ventilation period, up to 2 hours
Time frame: During each ventilation period, up to 2 hours
Contact information is provided by the study sponsor or research team.
Anatole DECAIX, MD
CONTACT
Xavier DURRMEYER, MD, PhD
CONTACT
Centre Hospitalier Intercommunal Creteil
Other
Diaphragmatic Activity During Constant or Variable Flow CPAP in Neonates: a Non-inferiority, Randomized, Alternating Treatments Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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