During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies
* Principal Objective: To show that IPV ventilation can decrease the duration of transient respiratory distress as well as the risk of complications. * Secondary Objective: Comparison between the two groups regarding: Length of oxygen therapy, complications (pneumothorax, pulmonary infections), need for intensive care hospitalization * Study design: Open, prospective randomized trial. * Inclusion criteria: Neonates with gestational age ≥ 35 weeks and weight ≥ 2000g, caesarean section, respiratory distress syndrome (modified Silverman score \> 5, SpO2 \< 90%), management within 20 minutes after birth. * Exclusion criteria: clinical thoracic retraction, congenital lung malformation, meconium aspiration, neonatal infection, other congenital malformations. * Study plan: After the screening evaluation and written consent document, neonates will be randomized into two groups: nCPAP ventilation or IPV. During the 6 hours after randomization, clinical data will be monitored: cardiac and respiratory frequency (CF -RF), saturation (SaO2), oxygenotherapy, Silverman Score. Then, neonates will be supervised 3 days after normalization of the respiratory distress. * Number of subjects: 100 (50 in each group)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Nasal Continuous Positive Airway Pressure ventilation
Intrapulmonary Percussive Ventilation
Néonatalogie - Maternité - Hôpital Pellegrin
Bordeaux, France
Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes
Time frame: Within the first 6 hours after birth
Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy
Time frame: Within the first 72 hours after birth
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