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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556738
First Posted: November 12, 2007
Last Update Posted: May 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Bordeaux
  Purpose
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 Intervention
Respiratory Distress Syndrome, Newborn Procedure: Nasal Continuous Positive Airway Pressure ventilation Procedure: Intrapulmonary Percussive Ventilation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

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

Estimated Enrollment: 100
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

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

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
  Contacts and Locations
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


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

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
2007-A00666-47
First Submitted: November 9, 2007
First Posted: November 12, 2007
Last Update Posted: May 13, 2010
Last Verified: May 2010

Keywords provided by University Hospital, Bordeaux:
HFPV
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