N/A
N=22
Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants
Respiratory Insufficiency · Infant, Newborn, Disease
Bottom Line
View on ClinicalTrials.gov: NCT02518230 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Respiratory Severity Score (MAP X FiO2) — 3.83; 3.82; 3.46; 3.86 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neurally Adjusted Ventilatory Assist (Device); Synchronized Interm. Mandatory Assist (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Jun 2015
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 | — |
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.
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
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.