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

Completed · Not applicable

Conditions studied: Respiratory Insufficiency, Infant, Newborn, Disease

In brief

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.

Key facts

Study ID

NCT02518230

Run by

Children's Mercy Hospital Kansas City

People needed

22

Starts

2014-01-01

Expected to finish

2015-06-01

Last updated by the study team

2021-07-23

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.