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

NCT02518230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-07-23

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Jamie L Rosterman, DO · Children's Mercy Hospital Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02518230 on ClinicalTrials.gov