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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT00556738

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Newborn	Procedure: Nasal Continuous Positive Airway Pressure ventilation Procedure: Intrapulmonary Percussive Ventilation	N/A

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [Within the first 6 hours after birth]

Secondary Outcome Measures

Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy [Within the first 72 hours after birth]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Néonatalogie - Maternité - Hôpital Pellegrin	Bordeaux		France	33076

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator: Clothilde Bertrand, Dr, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00556738

Other Study ID Numbers:

CHUBX 2007/09
2007-A00666-47

First Posted:

Nov 12, 2007

Last Update Posted:

May 13, 2010

Last Verified:

May 1, 2010

Keywords provided by , ,

HFPV

neonatal respiratory distress

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of May 13, 2010