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

NCT ID: NCT01389882

Last Updated: 2012-01-09

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

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

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

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=5 Participants	5 days n=7 Participants	5 days n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment Korea, Republic of	13 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants
Gestational Age	206 days STANDARD_DEVIATION 28 • n=5 Participants	212 days STANDARD_DEVIATION 20 • n=7 Participants	209 days STANDARD_DEVIATION 24 • n=5 Participants
Birth Weight	990 g n=5 Participants	1630 g n=7 Participants	1075 g n=5 Participants
Birth Height	37.2 cm STANDARD_DEVIATION 5.9 • n=5 Participants	38.3 cm STANDARD_DEVIATION 6.7 • n=7 Participants	37.7 cm STANDARD_DEVIATION 6.2 • n=5 Participants
Study Day Postmenstrual Age	220 days STANDARD_DEVIATION 20 • n=5 Participants	222 days STANDARD_DEVIATION 15 • n=7 Participants	221 days STANDARD_DEVIATION 18 • n=5 Participants
Study Day Body Weight	1210 g n=5 Participants	1530 g n=7 Participants	1355 g n=5 Participants
Capillary Blood pH	7.31 pH STANDARD_DEVIATION 0.04 • n=5 Participants	7.34 pH STANDARD_DEVIATION 0.06 • n=7 Participants	7.32 pH STANDARD_DEVIATION 0.05 • n=5 Participants
Capillary Blood pCO2	48.83 mmHg STANDARD_DEVIATION 8.93 • n=5 Participants	44.45 mmHg STANDARD_DEVIATION 6.34 • n=7 Participants	46.8 mmHg STANDARD_DEVIATION 8.00 • n=5 Participants
Capillary Blood pO2	37.77 mmHg STANDARD_DEVIATION 7.03 • n=5 Participants	37.00 mmHg STANDARD_DEVIATION 8.80 • n=7 Participants	37.42 mmHg STANDARD_DEVIATION 7.72 • n=5 Participants
Capillary Blood HCO3	24.20 mmol/L STANDARD_DEVIATION 3.45 • n=5 Participants	21.62 mmol/L STANDARD_DEVIATION 9.34 • n=7 Participants	23.02 mmol/L STANDARD_DEVIATION 6.78 • n=5 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

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

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

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

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

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

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

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

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

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

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

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

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: lamb4122@snu.ac.kr

Email: lamb4122@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place