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

NCT ID: NCT03250793

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2021-01-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Neonate with congenital diaphragmatic hernia

Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lélia Dreyfus, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bron, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 36807570 (View on PubMed)

Other Identifiers

2017-A02270-53

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0429

Identifier Type: -

Identifier Source: org_study_id