N/A Completed N=22 Randomized Treatment

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

Respiratory Insufficiency · Infant, Newborn, Disease

Source: ClinicalTrials.gov NCT02518230 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcomePrimary: Respiratory Severity Score (MAP X FiO2) — 3.83; 3.82; 3.46; 3.86 score on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Respiratory Severity Score (MAP X FiO2)	3.83; 3.82; 3.46; 3.86	—
SECONDARY Energy Expenditure	25.6	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02518230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.