Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants

Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV

This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes.

This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure.

It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Infant, Newborn, Disease
• Intervention / Treatment: Device: Neurally Adjusted Ventilatory Assist; Device: Synchronized Interm. Mandatory Assist

Detailed Description

This single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the NAVA or SIMV(PC) + PS modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and energy expenditure.

Infants will be screened for stability criteria including: being stable on the ventilator in either SIMV (PC) + PS or NAVA mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours.

After screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. After the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. Data will then be collected for 12 hours afterwards in the crossover mode. Data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. While in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Neonates and infants, 22 weeks gestation age or older at birth
• Require mechanical ventilation for respiratory support in either SIMV (PC) + PS or NAVA modes
• Stable on the ventilator with a fractional inspired oxygen requirement (FiO2) of 0.60 or less.
• Stable on the ventilator with weaning or unchanged ventilatory support without need of escalation of ventilatory pressure or rate in prior 12 hours.

Exclusion Criteria:

• Major congenital anomalies
• Neurologic compromise of respiratory drive
• Phrenic nerve palsy
• Sedated enough to suppress respiratory drive
• Respiratory support with volume mechanical ventilation
• Respiratory support with high frequency oscillatory ventilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Neurally Adjusted Ventilatory Assist; Subject will be randomized to NAVA ventilation. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.	Device: Neurally Adjusted Ventilatory Assist; The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist; Device: Synchronized Interm. Mandatory Assist; The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support
Other: Synchronized Interm. Mandatory Assist; Subject will be randomized to SIMV(PC)PS ventilation. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours.	Device: Neurally Adjusted Ventilatory Assist; The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist; Device: Synchronized Interm. Mandatory Assist; The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Severity Score (MAP X FiO2)	The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease.	12 hours and 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy Expenditure	The subject will have indirect calorimetry performed twice during the study on each mode, 12 hours after randomization and 12 hours after crossover to determine the approximate amount of energy expenditure needed for each mode of mechanical ventilation. Energy expenditure is calculated by using the Harris-Benedict equation, resulted in kcal/kg per day.	12 hours and 24 hours

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Jamie L Rosterman, DO, Children's Mercy Hospital Kansas City

Publications and helpful links

General Publications

• Rosterman JL, Pallotto EK, Truog WE, Escobar H, Meinert KA, Holmes A, Dai H, Manimtim WM. The impact of neurally adjusted ventilatory assist mode on respiratory severity score and energy expenditure in infants: a randomized crossover trial. J Perinatol. 2018 Jan;38(1):59-63. doi: 10.1038/jp.2017.154. Epub 2017 Oct 26.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Infant, Newborn, Diseases
• Other Study ID Numbers: Crossover NAVA