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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Newborn
• Interventions: Procedure: Intrapulmonary Percussive Ventilation; Procedure: Nasal Continuous Positive Airway Pressure ventilation

• Registration Number: NCT00556738
• Lead Sponsor: University Hospital, Bordeaux

Brief 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)

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-12
• Last Update Posted: 2010-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nHFPV	Intrapulmonary Percussive Ventilation	Intrapulmonary Percussive Ventilation
nCPAP	Nasal Continuous Positive Airway Pressure ventilation	Nasal Continuous Positive Airway Pressure ventilation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy	Within the first 72 hours after birth

Trial Locations

Locations (1)

Néonatalogie - Maternité - Hôpital Pellegrin; 🇫🇷 Bordeaux, France