Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation. (NAVA-DIAPH)

August 28, 2025 updated by: Hospices Civils de Lyon

Physiologic Pilot Study: Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in Post-surgical Period Alternatively in Conventional Ventilation (Pressure Controlled) and in NAVA (Neurally Adjusted Ventilatory Assist) Ventilation.

Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a synchronized proportional assisted ventilation. This technique has already been used in the newborn, especially premature and has shown many benefits. Only one study in the literature shows its feasibility in newborns with CDH. This technique seems interesting in the context of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating the clinical benefits, it seems important to describe the effects on the respiratory physiology, in particular on work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is an innovative physiologic pilot study with the objective to describe work of breathing in neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation using an esophageal transducer. It will provide the clinician with a physiological justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of these patients. This study is a prerequisite for the realization of studies demonstrating the clinical benefit of NAVA ventilation on reduction of duration of ventilation and more generally on morbidity and mortality in the population of neonate with CDH.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

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8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonate admitted to neonatal intensive care beyond 34 weeks of amenorrhea
  • With a diagnosis of congenital diaphragmatic hernia having undergone a repair surgery.
  • Necessary invasive ventilatory support by conventional ventilation
  • Informed and signed consent of parents (and / or holders of parental authority)

Exclusion Criteria:

  • Refusal of parents (and / or holders of parental authority) to participate in the study
  • Contra-indication to the use of an oro or naso-gastric tube (oesophageal surgery)
  • Child at risk of poor tolerance to the placement of the oesophageal pressure transducer (history of discomfort when placing a tube, weight <1500g)
  • Central or neuromuscular neurological pathology which may affect respiratory control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Neonate with congenital diaphragmatic hernia
Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation
Device: Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
While the patient is under respiratory assistance on the SERVO-I respirator, he will be included in the study and one esophageal transducer of 2,3 mm of diameter will be inserted through the mouth / nose in addition to NAVA's naso / Oro-Gastric tube( Edi Catheter, 6Fr, 49 cm, PHT free 5 pcs / pkg or Catheter Edi, 6Fr, 50 cm, PHT free 5 pcs / pkg). Measurements will be performed using the esophageal transducer under two conditions: 2 hours in conventional ventilation (pressure controlled), 2 hours in NAVA ventilation and then again 2 hours in conventional ventilation (PC) for a total duration of 6 hours.The parameters of conventional ventilation will be left free at the choice of the neonatologist and will be identical between the two periods of conventional ventilation. The initial NAVA level will be defined by the neonatologist using pre-visualization curves. All signals will be recorded via an amplification and acquisition system. Values will be averaged over 100 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
Time Frame: in post-surgical period during 6 hours
Work of breathing is estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
in post-surgical period during 6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-ventilator synchronization in NAVA
Time Frame: through study completion, an average of 1 year
Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
through study completion, an average of 1 year
Patient-ventilator synchronization in conventional ventilation
Time Frame: through study completion, an average of 1 year
Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in NAVA
Time Frame: through study completion, an average of 1 year
Intrinsic PEEP average over 100 cycles
through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.
Time Frame: through study completion, an average of 1 year
Intrinsic PEEP average over 100 cycles
through study completion, an average of 1 year
Ventilation parameters: peak inspiratory pressure in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: mean pressure in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: tidal volume in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: Ti / Ttot ratio in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: FiO2 in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: peak inspiratory pressure in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: mean pressure in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: tidal volume in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: Ti / Ttot ratio in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Ventilation parameters: FiO2 in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA
Time Frame: through study completion, an average of 1 year
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA
Time Frame: through study completion, an average of 1 year
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation
Time Frame: through study completion, an average of 1 year
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation
Time Frame: through study completion, an average of 1 year
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
through study completion, an average of 1 year
Clinical parameters of neonates: respiratory rate in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
through study completion, an average of 1 year
Clinical parameters of neonates: heart rate in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
through study completion, an average of 1 year
Clinical parameters of neonates: blood pressure in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
through study completion, an average of 1 year
Clinical parameters of neonates: respiratory rate in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
through study completion, an average of 1 year
Clinical parameters of neonates: heart rate in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
through study completion, an average of 1 year
Clinical parameters of neonates: blood pressure in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous SaO2 in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous pCO2 in NAVA
Time Frame: through study completion, an average of 1 year
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
through study completion, an average of 1 year
Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA
Time Frame: through study completion, an average of 1 year
Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
through study completion, an average of 1 year
Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation
Time Frame: through study completion, an average of 1 year
Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lélia Dreyfus, MD, Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

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  • 69HCL17_0429
  • 2017-A02270-53 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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