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

Newborn Morbidity Clinical Trial

Official title:

Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) on Respiratory Parameters in Newborns Receiving NAVA Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780842
• Other study ID #: Pilot breakpoint NAVA
• Status: Completed
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 28, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Newborn Morbidity

Intervention

Device:
• NAVA level
A titration protocol will be used for changing NAVA levels. The NAVA level will be reduced to 0,5 cmH2O/µV for 3 minutes as a starting point. Limit peak pressure will be set to 35cmH2O (i.e. according to the standard manufacturer's settings) the maximum pressure that can be delivered to the patient is cut off at 30cmH2O). Other ventilator settings will be left unchanged and are as clinically indicated. Ventilator settings will be according to our standard of care and as following: PEEP between 4 and 7 mmHg, apnea time 2-5 sec, back-up ventilation with a pressure above PEEP between 5 and 15 mmHg and a frequency between 30 and 50 per minute. Starting from a NAVA level of 0,5 cmH20/µV the level will be increased by 0,5 cmH2O/µV every 3 minutes until reaching a maximum NAVA level of 4,0 cmH2O/µV.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Julie Lefevere

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal NAVA level to unload the diaphragm	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.	24 minutes