Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Newborns

Not Applicable

Completed

• Conditions: Newborn Morbidity
• Interventions: Device: NAVA level

• Registration Number: NCT03780842
• Lead Sponsor: Julie Lefevere

Brief Summary

To examine the effect of changing levels of support during NAVA-ventilation ("NAVA-level") on electrical diaphragm activity of the newborn on invasive or non-invasive NAVA ventilation.

The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on NAVA ventilation in adults and children(1, 9), can be determined in newborn infants. Knowledge of this breakpoint will be used to optimise the settings of NAVA level at initiation of invasive or non-invasive NAVA ventilation.

This is an explorative study conducted in preparation of a randomized controlled trial that is planned in the near future to compare the effects of non-invasive NAVA with nasal continuous positive airway pressure (CPAP) in newborn infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Primary Completion: 2021-11-30
• Study Completion: 2022-02-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Newborns admitted to the NICU in need for respiratory support and put on invasive or non-invasive NAVA by the attending physician. Patients will be included when they are clinically stable and within 24h after starting NAVA or nivNAVA.

Exclusion Criteria

• • Congenital malformations of the diaphragm or respiratory system, including congenital diaphragmatic hernia.
• Patients with abnormalities of the upper airway (e.g. vocal cord paralysis, post-extubation laryngeal edema, Pierre-Robin sequence...).
• More than 20% of time spent in back-up ventilationWhen a patient on NAVA ventilation is apneic for a certain period of time (apnea time), the ventilator switches tot backup-ventilation. Backup-ventilation is pressure controlled, the apnea time can variate between 2 and 10 seconds.
• Clinically unstable patients:
• hemodynamic instability as defined by need of inotropic support or
• rapid respiratory deterioration on NAVA ventilation.
• No informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-invasive NAVA ventilation	NAVA level	A titration protocol will be used for changing NAVA levels in newborns with non-invasive NAVA ventilation (= with a nasal interface).
Invasive NAVA ventilation	NAVA level	A titration protocol will be used for changing NAVA levels in intubated newborns

Primary Outcome Measures

Name	Time	Method
Optimal NAVA level to unload the diaphragm	24 minutes	The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on NAVA ventilation in adults and children(1, 9), can be determined in newborn infants. Knowledge of this breakpoint will be used to optimise the settings of NAVA level at initiation of invasive or non-invasive NAVA ventilation.

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium