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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:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00556738
First received: November 9, 2007
Last updated: May 12, 2010
Last verified: May 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Bordeaux

Additional 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
Study First Received: November 9, 2007
Last Updated: May 12, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
HFPV
neonatal respiratory distress

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

ClinicalTrials.gov processed this record on November 27, 2014