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
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

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
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 22, 2014