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

NCT03250793 | Completed

• 2 other identifiers: 69HCL17_04292017-A02270-53
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia, DIaphragmatic, Congenital

Keywords

Hernia, DIaphragmatic, Congenital; Respiration, Artificial; physiologic pilot study; NAVA; Neurally Adjusted Ventilatory Assist; esophageal transducer; Work of Breathing

Outcome Measures

Primary Outcomes (1)

• Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation

  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 Outcomes (30)

• Patient-ventilator synchronization in NAVA

  through study completion, an average of 1 year

• Patient-ventilator synchronization in conventional ventilation

  through study completion, an average of 1 year

• Dynamic hyperinflation (intrinsic PEEP) in NAVA

  through study completion, an average of 1 year

• Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.

  through study completion, an average of 1 year

• Ventilation parameters: peak inspiratory pressure in NAVA

  through study completion, an average of 1 year

Study Arms (1)

Neonate with congenital diaphragmatic hernia

EXPERIMENTAL

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

Interventions

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.

Neonate with congenital diaphragmatic hernia

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

Related Publications (1)

• Dreyfus L, Butin M, Plaisant F, Claris O, Baudin F. Respiratory physiology during NAVA ventilation in neonates born with a congenital diaphragmatic hernia: The "NAVA-diaph" pilot study. Pediatr Pulmonol. 2023 May;58(5):1542-1550. doi: 10.1002/ppul.26357. Epub 2023 Mar 1.

  PMID: 36807570 BACKGROUND

MeSH Terms

Conditions

Hernia, Diaphragmatic; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Lélia Dreyfus, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 16, 2017
• Study Start: August 20, 2018
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)