Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress

NCT ID: NCT02030691

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-03-31

Brief Summary

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).

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).

Conditions

Neonatal Respiratory Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nasal continuous airway positive pressure (nCPAP)

Intervention Type: DEVICE

Nasal high frequency percussive ventilation (nHFPV)

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Nasal continuous airway positive pressure (nCPAP)

Intervention Type: DEVICE

Nasal high frequency percussive ventilation (nHFPV)

Intervention Type: DEVICE

Interventions

Nasal continuous airway positive pressure (nCPAP)

Intervention Type: DEVICE

Nasal high frequency percussive ventilation (nHFPV)

Intervention Type: DEVICE

Eligibility Criteria

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…

• Maximum Eligible Age: 30 Minutes
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent RENESME, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Antoine BENARD, MD

Role: STUDY_CHAIR

University Hospital Bordeaux, France

Locations

Service de Néonatalogie - Maternité - Hôpital Pellegrin

Bordeaux, Bordeaux, France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurent RENESME, MD

Role: CONTACT

laurent.renesme@chu-bordeaux.fr

+33 (0)5 56 79 55 39

Fabienne NACKA

Role: CONTACT

fabienne.nacka@chu-bordeaux.fr

+33 (0)5 57 82 01 08

Facility Contacts

Laurent RENESME, MD

Role: primary

laurent.renesme@chu-bordeaux.fr

+33 (0)5 56 79 55 39

Other Identifiers

CHUBX 2013/10

Identifier Type: -

Identifier Source: org_study_id