Trial Outcomes & Findings for Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants (NCT NCT02518230)

Results Overview

The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

12 hours and 24 hours

Results posted on

2021-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	NAVA Ventilation First, Then SIMV(PC)PS Ventilation Subject will be randomized to NAVA ventilation first. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours. Subjects will cross over. Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support	SIMV(PC)PS Ventilation First, Then NAVA Ventilation Subject will be randomized to SIMV(PC)PS ventilation first. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours. Subjects will cross over Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NAVA Ventilation First, Then SIMV(PC)PS Ventilation n=11 Participants Subject will be randomized to NAVA ventilation first. Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours. Subjects will cross over. Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support	SIMV(PC)PS Ventilation First, Then NAVA Ventilation n=11 Participants Subject will be randomized to SIMV(PC)PS ventilation first. Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours. subjects will cross over. Neurally Adjusted Ventilatory Assist: The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist Synchronized Interm. Mandatory Assist: The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 Post Menstral Age in weeks n=5 Participants	32 Post Menstral Age in weeks n=7 Participants	32 Post Menstral Age in weeks n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours and 24 hours

The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease.

Outcome measures

Outcome measures
Measure	NAVA Ventilation First, Then SIMV(PC)PS Ventilation n=11 Participants Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.	SIMV(PC)PS Ventilation First, Then NAVA Ventilation n=11 Participants Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours.
Respiratory Severity Score (MAP X FiO2) Respiratory severity score 12 h average	3.83 score on a scale Standard Deviation 2	3.82 score on a scale Standard Deviation 1.79
Respiratory Severity Score (MAP X FiO2) Respiratory severity score 24 h average	3.46 score on a scale Standard Deviation 2.24	3.86 score on a scale Standard Deviation 1.93

SECONDARY outcome

Timeframe: 12 hours and 24 hours

Population: This outcome measure was not broken down by intervention as it is a median of energy expenditure for all participants enrolled. The data herein are cumulative for all study participants.

The subject will have indirect calorimetry performed twice during the study on each mode, 12 hours after randomization and 12 hours after crossover to determine the approximate amount of energy expenditure needed for each mode of mechanical ventilation. Energy expenditure is calculated by using the Harris-Benedict equation, resulted in kcal/kg per day.

Outcome measures

Outcome measures
Measure	NAVA Ventilation First, Then SIMV(PC)PS Ventilation n=22 Participants Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.	SIMV(PC)PS Ventilation First, Then NAVA Ventilation Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours.
Energy Expenditure	25.6 kcal/kg per day Interval 16.1 to 46.5	—

Adverse Events

NAVA Ventilation First, Then SIMV(PC)PS Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SIMV(PC)PS Ventilation First, Then NAVA Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Winston Manimtim

Children's Mercy Hospital

Phone: 816-234-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place