NCT00556738

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

* 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)

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
PROCEDURE	Nasal Continuous Positive Airway Pressure ventilation	Nasal Continuous Positive Airway Pressure ventilation
PROCEDURE	Intrapulmonary Percussive Ventilation	Intrapulmonary Percussive Ventilation

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-11-12
• Last updated: 2010-05-13

Locations

1 site across 1 country: France