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

University Hospital of Bordeaux

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Procedure: Intrapulmonary Percussive Ventilation; Procedure: Nasal Continuous Positive Airway Pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00556738

CHUBX 2007/09

2007-A00666-47

Details and patient eligibility

About

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

Full 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)

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

nHFPV

Experimental group

Description:

Intrapulmonary Percussive Ventilation

Treatment:

Procedure: Intrapulmonary Percussive Ventilation

nCPAP

Active Comparator group

Description:

Nasal Continuous Positive Airway Pressure ventilation

Treatment:

Procedure: Nasal Continuous Positive Airway Pressure ventilation