Trial Outcomes & Findings for Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants (NCT NCT01389882)

Results Overview

peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

four hours

Results posted on

2012-01-09

Participant Flow

Participants recruited from a neonatal intensive care unit (NICU) of Seoul National University Hospital, in Seoul, Republic of Korea between March 2011 to July 2011.

26 patients enrolled; 24 assigned to randomization and 2 excluded (1 extubated prior to the study and 1 developed exclusion criteria)

Participant milestones

Participant milestones
Measure	SN Group Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)	NS Group NAVA first, then SIMV with PS
Overall Study STARTED	13	11
Overall Study COMPLETED	12	7
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	SN Group Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)	NS Group NAVA first, then SIMV with PS
Overall Study Respiratory rate > 80/min during study	1	3
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SN Group n=13 Participants Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)	NS Group n=11 Participants NAVA first, then SIMV with PS	Total n=24 Participants Total of all reporting groups
Age Continuous	7 days n=99 Participants	5 days n=107 Participants	5 days n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	0 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	11 Participants n=107 Participants	17 Participants n=206 Participants
Region of Enrollment Korea, Republic of	13 participants n=99 Participants	11 participants n=107 Participants	24 participants n=206 Participants
Gestational Age	206 days STANDARD_DEVIATION 28 • n=99 Participants	212 days STANDARD_DEVIATION 20 • n=107 Participants	209 days STANDARD_DEVIATION 24 • n=206 Participants
Birth Weight	990 g n=99 Participants	1630 g n=107 Participants	1075 g n=206 Participants
Birth Height	37.2 cm STANDARD_DEVIATION 5.9 • n=99 Participants	38.3 cm STANDARD_DEVIATION 6.7 • n=107 Participants	37.7 cm STANDARD_DEVIATION 6.2 • n=206 Participants
Study Day Postmenstrual Age	220 days STANDARD_DEVIATION 20 • n=99 Participants	222 days STANDARD_DEVIATION 15 • n=107 Participants	221 days STANDARD_DEVIATION 18 • n=206 Participants
Study Day Body Weight	1210 g n=99 Participants	1530 g n=107 Participants	1355 g n=206 Participants
Capillary Blood pH	7.31 pH STANDARD_DEVIATION 0.04 • n=99 Participants	7.34 pH STANDARD_DEVIATION 0.06 • n=107 Participants	7.32 pH STANDARD_DEVIATION 0.05 • n=206 Participants
Capillary Blood pCO2	48.83 mmHg STANDARD_DEVIATION 8.93 • n=99 Participants	44.45 mmHg STANDARD_DEVIATION 6.34 • n=107 Participants	46.8 mmHg STANDARD_DEVIATION 8.00 • n=206 Participants
Capillary Blood pO2	37.77 mmHg STANDARD_DEVIATION 7.03 • n=99 Participants	37.00 mmHg STANDARD_DEVIATION 8.80 • n=107 Participants	37.42 mmHg STANDARD_DEVIATION 7.72 • n=206 Participants
Capillary Blood HCO3	24.20 mmol/L STANDARD_DEVIATION 3.45 • n=99 Participants	21.62 mmol/L STANDARD_DEVIATION 9.34 • n=107 Participants	23.02 mmol/L STANDARD_DEVIATION 6.78 • n=206 Participants

PRIMARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Peak Inspiratory Pressure	13.45 cmH2O Standard Deviation 3.44	12.45 cmH2O Standard Deviation 2.66

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

mean airway pressure measured by a ventilator for 4 hours with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Mean Airway Pressure	7.99 cmH2O Standard Deviation 1.33	8.02 cmH2O Standard Deviation 1.23

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Minute ventilation measured by a ventilator for 4 hours with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Minute Ventilation	0.53 L/min/Kg Standard Deviation 0.15	0.51 L/min/Kg Standard Deviation 0.11

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Expiratory Tidal Volume	8.73 mL/Kg Standard Deviation 2.08	8.54 mL/Kg Standard Deviation 2.24

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Dynamic Compliance	1.70 mL/cmH2O Standard Deviation 0.47	1.84 mL/cmH2O Standard Deviation 0.36

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Work of Breathing	11.13 mJ/L Interval 3.92 to 60.79	8.38 mJ/L Interval 1.6 to 30.21

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Peak electrical activity of the diaphragm

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Peak EAdi	13.39 uV Standard Deviation 5.68	11.70 uV Standard Deviation 5.72

SECONDARY outcome

Timeframe: four hours

Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Fraction of Oxygen	23.33 percentage of concentration Interval 21.08 to 41.18	23.47 percentage of concentration Interval 20.75 to 39.07

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Capillary Blood pH	7.327 pH Standard Deviation 0.051	7.334 pH Standard Deviation 0.046

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Capillary Blood pCO2	46.75 mmHg Standard Deviation 7.43	46.64 mmHg Standard Deviation 7.87

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Capillary Blood pO2	38.89 mmHg Standard Deviation 8.82	37.84 mmHg Standard Deviation 8.51

SECONDARY outcome

Timeframe: four hours

Population: The analysis was "per protocol". 19 patients who had completed the study was used for the analysis.

Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode

Outcome measures

Outcome measures
Measure	SIMV With PS n=19 Participants synchronized intermittent mandatory ventilation with pressure support	NAVA n=19 Participants neurally adjusted ventilatory assist
Capillary Blood HCO3	24.46 mmol/L Standard Deviation 3.95	24.74 mmol/L Standard Deviation 3.57

Adverse Events

SN Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NS Group

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

Dr. Juyoung Lee

Seoul National University Hospital

Phone: [email protected]

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place