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Completed

NCT Number: NCT03250793

Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional 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.

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Key information

Conditions

Hernia, DIaphragmatic, Congenital Hernia Hernia, Diaphragmatic Internal Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. Dynamic hyperinflation (intrinsic PEEP) in NAVA

    Time frame: through study completion, an average of 1 year

    Intrinsic PEEP average over 100 cycles

  4. Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.

    Time frame: through study completion, an average of 1 year

    Intrinsic PEEP average over 100 cycles

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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.

Acronym: NAVA-DIAPH

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2017
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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