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:	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

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 - French Health Products Safety Agency

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 February 09, 2012