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

Sponsor:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00556738

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:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial

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
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
nHFPV: Experimental Intrapulmonary Percussive Ventilation	Procedure: Intrapulmonary Percussive Ventilation Intrapulmonary Percussive Ventilation
nCPAP: Active Comparator 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

Contacts

Contact: Christophe Elleau, Dr	(33)(5) 56 79 55 39	christophe.elleau@chu-bordeaux.fr
Contact: Fabienne Nacka, PhD	(33)(5)57 82 00 03	fabienne.nacka@chu-bordeaux.fr

Locations

France
Néonatalogie - Maternité - Hôpital Pellegrin	Recruiting
Bordeaux, France, 33076
Contact: Christophe Elleau, Dr (33)(5) 56 79 55 39 christophe.elleau@chu-bordeaux.fr
Contact: Fabienne , Nacka (33)(5) 57 82 00 03 fabienne.nacka@chu-bordeaux.fr
Principal Investigator: Clothilde Bertrand, Dr
Sub-Investigator: Christophe Elleau, Dr

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:

Clothilde Bertrand, Dr

University Hospital, Bordeaux

More Information

No publications provided

Responsible Party:	University hospital, Bordeaux ( Jean-Pierre LEROY / Clinical research and Innovation director )
Study ID Numbers:	CHUBX 2007/09, 2007-A00666-47
Study First Received:	November 9, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00556738 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

HFPV
neonatal respiratory distress

Additional relevant MeSH terms:

Pathologic Processes
Disease
Respiratory Tract Diseases
Lung Diseases
Syndrome

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

ClinicalTrials.gov processed this record on February 08, 2010