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

NCT02518230 | Completed Results DMC

• 1 other identifier: Crossover NAVA
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Insufficiency; Infant, Newborn, Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Energy Expenditure

  12 hours and 24 hours

Study Arms (2)

Neurally Adjusted Ventilatory Assist

OTHER

Subject will be randomized to NAVA ventilation. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.

Device: Neurally Adjusted Ventilatory Assist; Device: Synchronized Interm. Mandatory Assist

Synchronized Interm. Mandatory Assist

OTHER

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; Device: Synchronized Interm. Mandatory Assist

Interventions

Neurally Adjusted Ventilatory Assist DEVICE

The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist

Neurally Adjusted Ventilatory Assist; Synchronized Interm. Mandatory Assist

Synchronized Interm. Mandatory Assist DEVICE

The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support

Neurally Adjusted Ventilatory Assist; Synchronized Interm. Mandatory Assist

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• 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.

  PMID: 29072677 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Disease

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Winston Manimtim
• Organization: Children's Mercy Hospital

wmmanimtim@cmh.edu

816-234-3000

Study Officials

• Jamie L Rosterman, DO

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 7, 2015
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 23, 2021
• Results First Posted: July 23, 2021

Record last verified: 2021-06

Locations

US (1)