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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00556738

Acronym

HFPV

Enrollment

100

Registered

2007-11-12

Start date

2007-11-30

Completion date

2009-12-31

Last updated

2010-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

HFPV, neonatal respiratory distress

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)

Interventions

PROCEDURENasal Continuous Positive Airway Pressure ventilation

Nasal Continuous Positive Airway Pressure ventilation

PROCEDUREIntrapulmonary Percussive Ventilation

Intrapulmonary Percussive Ventilation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026