Neonatal Respiratory Distress
Conditions
Keywords
Continuous Positive Airway Pressure (CPAP), Variable flow Continuous Positive Airway Pressure (VF-CPAP), Constant flow Continuous Positive Airway Pressure (CF-CPAP), Respiratory Effort, Infant comfort, Diaphragmatic electrical activity (EADi)
Brief 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.
Detailed description
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.
Interventions
DEVICECF-CPAP; CF-CPAP; VF-CPAP; VF-CPAP
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).
DEVICEVF-CPAP; VF-CPAP; CF-CPAP; CF-CPAP
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).
DEVICECF-CPAP; VF-CPAP; VF-CPAP; CF-CPAP
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).
DEVICEVF-CPAP; CF-CPAP; CF-CPAP; VF-CPAP
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).
Sponsors
Centre Hospitalier Intercommunal Creteil
Pr Xavier DURRMEYER
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
72 Years to 10 Weeks
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean swing EAdi (µV) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COMFORTneo score | 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 : * excessive: score \<11 * appropriate: score between 11 to 13 * insufficient : score \>13 |
| Transcutaneous CO2 pressure TcPCO2 (mm Hg) | 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 | — |
Countries
France
Contacts
CONTACTXavier DURRMEYER, MD, PhD
CONTACTAnatole DECAIX, MD
Outcome results
None listed