Clinical trial NCT02518230: Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants
Official title: Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Infant, Newborn, Disease
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 22
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: This single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the NAVA or 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 energy expenditure.

Infants will be screened for stability criteria including: being stable on the ventilator in either SIMV (PC) + PS or NAVA mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours.

After screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. After the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. Data will then be collected for 12 hours afterwards in the crossover mode. Data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. While in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode.

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

Primary outcomes:
measure: Respiratory Severity Score (MAP X FiO2)
timeFrame: 12 hours and 24 hours
Secondary outcomes:
measure: Energy Expenditure
timeFrame: 12 hours and 24 hours
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Jamie L Rosterman, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.