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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-12-31

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

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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)

Conditions

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Respiratory Distress Syndrome, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nHFPV

Intrapulmonary Percussive Ventilation

Group Type EXPERIMENTAL

Intrapulmonary Percussive Ventilation

Intervention Type PROCEDURE

Intrapulmonary Percussive Ventilation

nCPAP

Nasal Continuous Positive Airway Pressure ventilation

Group Type ACTIVE_COMPARATOR

Nasal Continuous Positive Airway Pressure ventilation

Intervention Type PROCEDURE

Nasal Continuous Positive Airway Pressure ventilation

Interventions

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Nasal Continuous Positive Airway Pressure ventilation

Intervention Type PROCEDURE

Intrapulmonary Percussive Ventilation

Intervention Type PROCEDURE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No