NCT03250793: NAVA-DIAPH

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

Completed NA Last updated 4 September 2025

What this trial tests

NA trial testing Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer in Hernia, DIaphragmatic, Congenital in 8 participants. Completed in 20 January 2021.

Timeline

20 August 2018

Primary endpoint
20 January 2021

20 January 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	8
Start date	20 August 2018
Primary completion	20 January 2021
Estimated completion	20 January 2021
Sites	1 location across France

Drugs / interventions tested

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

Conditions studied

• Hernia, DIaphragmatic, Congenital — all drugs for Hernia, DIaphragmatic, Congenital →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

1 and older, any sex, with Hernia, DIaphragmatic, Congenital. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.