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

Sponsor

Julie Lefevere (Other)

Overall Status

Recruiting

CT.gov ID

NCT03780842

Collaborator

(none)

Enrollment

Location

Arms

30.7

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Newborn Morbidity	Device: NAVA level	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, interventional, exploratory study in a convenience sampleProspective, interventional, exploratory study in a convenience sample

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 10, 2018

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Invasive NAVA ventilation A titration protocol will be used for changing NAVA levels in intubated newborns	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.
Experimental: Non-invasive NAVA ventilation A titration protocol will be used for changing NAVA levels in newborns with non-invasive NAVA ventilation (= with a nasal interface).	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.

Arm

Intervention/Treatment

Experimental: Invasive NAVA ventilation

A titration protocol will be used for changing NAVA levels in intubated newborns

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.

Experimental: Non-invasive NAVA ventilation

A titration protocol will be used for changing NAVA levels in newborns with non-invasive NAVA ventilation (= with a nasal interface).

Device: NAVA level

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 20 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussel	Jette		Belgium	1090

Sponsors and Collaborators

Julie Lefevere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Julie Lefevere, Resident, Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT03780842

Other Study ID Numbers:

Pilot breakpoint NAVA

First Posted:

Dec 19, 2018

Last Update Posted:

Jan 19, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 19, 2021