Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

sNIPPV Versus NIV-NAVA in Extremely Premature Infants (EASYNNEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068558
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief Summary:

The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchronized nasal intermittent positive pressure ventilation (sNIPPV) using the Infant Flow CPAP device (Care Fusion, USA).

All of the data obtained can be used to develop a large-scale study aimed at reducing the rate of re-intubation in the study population (pilot study). In fact, the re-intubation criteria for extremely premature children are based on clinical criteria (desaturations, apnea, signs of respiratory control) and paraclinical criteria (FiO2, Potential hydrogen (pH), PCO2).

The results of this pilot study will help to develop an adapted methodology and to calculate a sample size to compare the 2 modes of NIV to the test on a clinical criterion: the rate of re-intubation after extubation, which is classically high in these patients.


Condition or disease Intervention/treatment Phase
Premature Birth Ventilator Lung; Newborn Device: VNI-NAVA/sNIPPV Device: sNIPPV/VNI-NAVA Not Applicable

Detailed Description:

The use of non-invasive ventilation has significantly reduced morbidity and mortality in premature newborns by reducing the pulmonary lesions caused by invasive ventilation. Currently, variable flow continuous positive airway pressure (CPAP) devices, such as the infant flow® driver, are considered more efficient than constant flow pressure sources. Nasal intermittent positive pressure ventilation, as compared to CPAP, might reduce the extubation failure rate, but has no impact on mortality or bronchopulmonary dysplasia. However, data is lacking on the interest of synchronization and on the effect of the different available interfaces (prongs, masks, cannulas). In addition, the ventilatory characteristics (high respiratory rate and low inspiratory effort) of the premature infant increase the risk of asynchrony between the patient and the ventilator, which is a major cause of poor tolerance for this type of ventilation.

NAVA (neurally adjusted ventilatory assist) is a recent ventilatory mode that offers proportional assistance to respiratory work based on the measured electrical activity of the diaphragm via oesophageal electrodes. It thus allows a regulation of inspiratory pressures and time by the patient him/herself. The physiological effects of NAVA have been primarily described in intubated neonates and studies have shown a significantly improved synchronization and significantly decreased inspiratory pressures in patients ventilated with NAVA compared to intermittent controlled ventilatory support. However, the currently available evidence is limited and no beneficial effect on morbidity or mortality has been identified so far .

There are few studies on noninvasive NAVA (NIV-NAVA) conducted exclusively in neonates, most of which included a limited number of patients. Only one study to date compared NIV-NAVA to another synchronized NIV mode (NIV pressure support) using the Servo-i ventilator. This prospective crossover study found a significant decrease in peak inspiratory pressure (PIP), FiO2, frequency and length of desaturations in the NIV-NAVA group.

Decreased asynchrony has been observed during NIV-NAVA as compared to pressure-support NIV In adult patients and in 6 children hospitalized in the Pediatric ICU (median age 18 months).

In premature neonates, variable flow CPAP is preferentially used. Synchronized intermittent positive pressure can be delivered using a variable flow device and a Graseby abdominal capsule. Since variable flow CPAP is considered the most efficient pressure generator, it is legitimate to compare synchronization performance of the variable flow synchronized nasal intermittent positive pressure ventilation (sNIPPV) to NIV-NAVA. This comparison has never been performed so far, to our knowledge.

We hypothesize that synchronization will be markedly improved with NIV-NAVA as compared to sNIPPV.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized crossover trial in the Neonatal Intensive Care Unit
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Synchronized Nasal Intermittent Positive Pressure Ventilation Versus Noninvasive Neurally Adjusted Ventilatory Assist Ventilation in Extremely Premature Infants: a Randomized Crossover Trial
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VNI-NAVA/sNIPPV
Ventilation of the child non-invasive ventilation (VNI) NAVA then sNIPPV
Device: VNI-NAVA/sNIPPV
Ventilation of the child in NIV-NAVA for 2 hours then ventilation of the child in sNIPPV for two hours. The ventilation periods consist of one hour of wash-out and one hour of data collection

Experimental: sNIPPV/VNI-NAVA
Ventilation of the child sNIPPV then non-invasive ventilation (VNI) NAVA
Device: sNIPPV/VNI-NAVA
Ventilation of the child in sNIPPV for 2 hours then ventilation of the child in NIV-NAVA for two hours. The ventilation periods consist of one hour of wash-out and one hour of data collection




Primary Outcome Measures :
  1. Asynchrony index [ Time Frame: 4 hours ]
    Asynchrony index as previously defined in the literature using the following parameters: Ineffective effort (IE): presence of an inspiratory electromyographic signal not followed by pressurization; Late cycling (LC): a cycle with an inspiratory time greater than twice the patient's neural inspiratory time; Premature cycling (PC): a cycle with an inspiratory time shorter than the the neural inspiratory time; Double triggering (DT): two ventilator-delivered cycles triggered by one neural inspiration; Auto triggering (AT): a cycle delivered by the ventilator in the absence of EAdi signal.


Secondary Outcome Measures :
  1. Components of the Asynchrony index [ Time Frame: 4 hours ]
    Each component of the Asynchrony index will be compared between the 2 ventilatory modes.

  2. Mean change in electric activity of the diaphragm (Edi) [ Time Frame: 4 hours ]
    Analyze as exploratory data of Mean delta Edi (max-min value) in NIV NAVA vs sNIPPV

  3. Apnoea [ Time Frame: 4 hours ]
    Analyze as exploratory data of Frequency of apnoea

  4. Desaturations [ Time Frame: 4 hours ]
    Analyze as exploratory data of Frequency of desaturations below 80%

  5. Bradycardia [ Time Frame: 4 hours ]
    Analyze as exploratory data of Frequency of bradycardia < 100 bpm

  6. ComfortNeo score [ Time Frame: 4 hours ]
    Analyze as exploratory data of Comfort Neo score assessed by the nurse before and after each ventilation period

  7. transcutaneous PCO2 [ Time Frame: 4 hours ]
    TcPCO2 modeling over time and comparison between NIV Nava and sNIPPV

  8. Nava level [ Time Frame: 1 hour ]
    Description of Nava levels used during NIV Nava

  9. Inspiratory pressure during sNIPPV [ Time Frame: 1 hour ]
    Description of inspiratory pressures used during sNIPPV

  10. Bag-mask ventilation or re-intubation [ Time Frame: 4 hours ]
    Frequency of bag-mask ventilation or re-intubation

  11. Re-intubation within 7 days [ Time Frame: 7 days ]
    Frequency of re-intubation within 7 days of randomization

  12. Fi02 [ Time Frame: 4 hours ]
    FiO2 changes over time during NIV NAVA and sNIPPV



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Premature infants born before 28 weeks of gestation
  • Corrected age below 32 weeks of gestation
  • Postnatal age > or = 3 days
  • Receiving NIPPV (any mode)
  • Equipped with an Edi catheter
  • Receiving caffein treatment
  • Parental consent
  • Recipient of French social security coverage

Non-inclusion criteria:

  • More than 1 apnea/hour requiring bag-mask ventilation, or pH<7.2 and/or TcPCO2>70, or FiO2>0.6 in the previous 6 hours.
  • Nasal trauma precluding the use of non-invasive ventilation
  • Major congenital anomalies
  • Grade III or higher intraventricular hemorrhage
  • Use of anesthetics or sedative within the past 24 hours, except opioids for iatrogenic withdrawal treatment
  • Hemodynamic compromise defined as a mean blood pressure less than gestational age (in mmHg) or a capillary refill time more than 3 seconds
  • Neuro-muscular disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068558


Contacts
Layout table for location contacts
Contact: Camille JUNG, MD 01 57 02 22 68 camille.jung@chicreteil.fr

Locations
Layout table for location information
France
Centre Hospitalier Intercommunal de Créteil Recruiting
Créteil, France, 94000
Contact: Xavier Durrmeyer, MD    +33673732017    xavier.durrmeyer@chicreteil.fr   
Principal Investigator: Xavier Durrmeyer, MD         
Sub-Investigator: Claude Danan, MD         
Sub-Investigator: Charles Treussart, MD         
Sub-Investigator: Fabrice Decobert, MD         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Layout table for additonal information
Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT04068558    
Other Study ID Numbers: EASYNNEO
2019-A00420-57 ( Other Identifier: ID-RCB )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal Creteil:
neurally adjusted ventilatory assist
synchronized nasal intermittent positive pressure ventilation
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchopulmonary Dysplasia
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases