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

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ClinicalTrials.gov Identifier: NCT00556738
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : May 13, 2010
Information provided by:
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

Condition or disease Intervention/treatment
Respiratory Distress Syndrome, Newborn Procedure: Nasal Continuous Positive Airway Pressure ventilation Procedure: Intrapulmonary Percussive Ventilation

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial
Study Start Date : November 2007
Primary Completion Date : December 2009
Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: nHFPV
Intrapulmonary Percussive Ventilation
Procedure: Intrapulmonary Percussive Ventilation
Intrapulmonary Percussive Ventilation
Active Comparator: nCPAP
Nasal Continuous Positive Airway Pressure ventilation
Procedure: Nasal Continuous Positive Airway Pressure ventilation
Nasal Continuous Positive Airway Pressure ventilation

Primary Outcome Measures :
  1. 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 [ Time Frame: Within the first 6 hours after birth ]

Secondary Outcome Measures :
  1. Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy [ Time Frame: Within the first 72 hours after birth ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556738

Néonatalogie - Maternité - Hôpital Pellegrin
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Principal Investigator: Clothilde Bertrand, Dr University Hospital, Bordeaux

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Pierre LEROY / Clinical research and Innovation director, University hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00556738     History of Changes
Other Study ID Numbers: CHUBX 2007/09
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: May 2010

Keywords provided by University Hospital, Bordeaux:
neonatal respiratory distress

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases