Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress (TONIPEP)

Tolerance of Nasal High Frequency Percussive Ventilation Versus Nasal CPAP in Neonatal Respiratory Distress in Term and Preterm (> 33 Weeks of Gestation) Neonates

Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.

We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy (NIRS).

Study Overview

• Status: Unknown
• Conditions: Neonatal Respiratory Distress
• Intervention / Treatment: Device: Nasal continuous airway positive pressure (nCPAP); Device: Nasal high frequency percussive ventilation (nHFPV)

Detailed Description

The objective is to compare nHFPV versus nCPAP tolerance for providing PEEP in newborn respiratory distress.

High frequency percussive ventilation (HFPV) is a pressure limited, time-cycled, high-frequency mode of ventilation that delivers subphysiologic tidal volumes at rapid rates and that can be used via an endotracheal tube, a nasal probe or a face mask. In burned children, it has been shown to provide the same or improved oxygenation and ventilation at lower peak pressure when compared with conventional ventilation. In neonates, HFPV has been described in hyaline membrane disease and acute respiratory failure ventilation with improvement in oxygenation, significant decrease in PaCO2 and no change in central hemodynamics and we recently shown that nasal HFPV is more effective than nasal continuous positive airway pressure in transient tachypnea of the newborn. This stud is a cross-over clinical trial. For each patient enrolled, the 2 respiratory devices (nHFPV and nCPAP) were used one after the other for 15 minutes each. Randomization determines which device to use in first (group A nCPAP then nHFPV, group B (nHFPV then nCPAP). During the experiment, rSO2c is continuously recorded by NIRS, and oxygenation and capnia are monitored in a non invasive way by transcutaneous oxygen saturation and transcutaneous capnia measurement. Ventilators' setting (PEEP, FiO2) will be modified to achieve oxygen and capnia targets (SpO2 > 90%, and under 95% if FiO2>0.21, Capnia between 5 to 7 kPa). Duration of patient follow up is 30 minutes. After these 30 minutes, if PEEP is always needed, patients undergo nCPAP. If needed during the experiment, patients can receive mechanical ventilation (the criteria for mechanical ventilation are the same as those used in clinical practice).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent RENESME, MD; Phone Number: +33 (0)5 56 79 55 39; Email: laurent.renesme@chu-bordeaux.fr
• Study Contact Backup: Name: Fabienne NACKA; Phone Number: +33 (0)5 57 82 01 08; Email: fabienne.nacka@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • Service de Néonatalogie - Maternité - Hôpital Pellegrin
    • Contact: Laurent RENESME, MD; Phone Number: +33 (0)5 56 79 55 39; Email: laurent.renesme@chu-bordeaux.fr
    • Sub-Investigator: Christophe ELLEAU, MD
    • Sub-Investigator: Eric DUMAS DE LA ROQUE, MD
    • Sub-Investigator: Olivier TANDONNET, MD
    • Sub-Investigator: Lorraine DELCROIX, MD
    • Principal Investigator: Laurent RENESME, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 30 minutes (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inborn neonate.
• Delivered by vaginal delivery or caesarean section.
• Gestational age greater than or equal to 33 weeks of gestation.
• Birth weight > 1kg.
• Respiratory distress with a Silverman score greater than or equal to 4 after 10 minutes of life.
• Signed parental informed consent.

Exclusion Criteria:

• Meconium aspiration syndrome.
• Congenital anomalies such as heart anomalies, congenital cystic adenomatoid malformation, diaphragmatic hernia…

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nCPAP - nHFPV; Eligible patient received after randomization nCPAP or nHFPV for 15 minutes then after the 15 minutes, they received the seconde non invasive device for 15 minutes. Study end 30 minutes after randomization or before if mechanical ventilation is required.	Device: Nasal continuous airway positive pressure (nCPAP); Device: Nasal high frequency percussive ventilation (nHFPV)
Experimental: nHFPV - nCPAP; Eligible patient received after randomization nCPAP or nHFPV for 15 minutes then after the 15 minutes, they received the seconde non invasive device for 15 minutes. Study end 30 minutes after randomization or before if mechanical ventilation is required.	Device: Nasal continuous airway positive pressure (nCPAP); Device: Nasal high frequency percussive ventilation (nHFPV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of cerebral tissue oxygenation (rSO2c) by near infrared spectroscopy (NIRS). We compared the mean of the variation of rSO2c during the last 5 minutes for each device (nHFPV and nCPAP).	30 minutes after the inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of transcutaneous capnia and oxygen saturation; variation of heart rate, breath rate and blood pressure; ventilators' setting (PEEP, FiO2).	30 minutes after the inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Laurent RENESME, MD, University Hospital Bordeaux, France

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Neonatal respiratory distress; nHFPV; nCPAP; cerebral tissue oxygenation; NIRS
• 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 2013/10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No