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

Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Procedure: Intrapulmonary Percussive Ventilation; Procedure: 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)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Néonatalogie - Maternité - Hôpital Pellegrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy	Within the first 72 hours after birth

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Clothilde Bertrand, Dr, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Dumas De La Roque E, Bertrand C, Tandonnet O, Rebola M, Roquand E, Renesme L, Elleau C. Nasal high frequency percussive ventilation versus nasal continuous positive airway pressure in transient tachypnea of the newborn: a pilot randomized controlled trial (NCT00556738). Pediatr Pulmonol. 2011 Mar;46(3):218-23. doi: 10.1002/ppul.21354. Epub 2010 Oct 20.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: November 9, 2007
• First Submitted That Met QC Criteria: November 9, 2007
• First Posted (ESTIMATE): November 12, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2010
• Last Update Submitted That Met QC Criteria: May 12, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: HFPV; neonatal respiratory distress
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: CHUBX 2007/09; 2007-A00666-47