Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn

Study Overview
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Brief Summary
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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

Detailed Description
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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)

Official Title
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Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial

Conditions
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Respiratory Distress Syndrome, Newborn

Intervention / Treatment
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* Procedure: Nasal Continuous Positive Airway Pressure ventilation
* Procedure: Intrapulmonary Percussive Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caesarean newborn Gestational age ≥ 35 weeks Weight ≥ 2 kg SaO2 < 90% after 10 min of life Silverman score ≥ 5 Treated less than 20 min after birth Social security affiliation (parents) Informed consent signed (parents) Exclusion Criteria: Thoracic retraction Congenital intrathoracic malformations Meconium aspiration Early neonatal infections with hemodynamic troubles Severe neonatal asphyxia Polymalformative syndrome
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nHFPV<br>Intrapulmonary Percussive Ventilation | Procedure: Intrapulmonary Percussive Ventilation<br>* Intrapulmonary Percussive Ventilation<br>|
| Active Comparator: nCPAP<br>Nasal Continuous Positive Airway Pressure ventilation | Procedure: Nasal Continuous Positive Airway Pressure ventilation<br>* Nasal Continuous Positive Airway Pressure ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Within the first 6 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy |  | Within the first 72 hours after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFPV, neonatal respiratory distress