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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389882
Recruitment Status : Completed
First Posted : July 8, 2011
Results First Posted : October 28, 2011
Last Update Posted : January 9, 2012
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition: Infant, Preterm
Intervention: Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
26 patients enrolled; 24 assigned to randomization and 2 excluded (1 extubated prior to the study and 1 developed exclusion criteria)

Reporting Groups
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

Participant Flow:   Overall Study
    SN Group   NS Group
STARTED   13   11 
COMPLETED   12   7 
Respiratory rate > 80/min during study                1                3 
Withdrawal by Subject                0                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
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
Total Total of all reporting groups

Baseline Measures
   SN Group   NS Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   11   24 
[Units: Days]
Median (Full Range)
 (2 to 57) 
 (2 to 70) 
 (2 to 70) 
[Units: Participants]
Female   7   0   7 
Male   6   11   17 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   13   11   24 
Gestational Age 
[Units: Days]
Mean (Standard Deviation)
 206  (28)   212  (20)   209  (24) 
Birth Weight 
[Units: g]
Median (Full Range)
 (370 to 2510) 
 (710 to 2510) 
 (370 to 2510) 
Birth Height 
[Units: Cm]
Mean (Standard Deviation)
 37.2  (5.9)   38.3  (6.7)   37.7  (6.2) 
Study Day Postmenstrual Age 
[Units: Days]
Mean (Standard Deviation)
 220  (20)   222  (15)   221  (18) 
Study Day Body Weight 
[Units: g]
Median (Full Range)
 (670 to 2530) 
 (750 to 2580) 
 (670 to 2580) 
Capillary Blood pH 
[Units: pH]
Mean (Standard Deviation)
 7.31  (0.04)   7.34  (0.06)   7.32  (0.05) 
Capillary Blood pCO2 
[Units: mmHg]
Mean (Standard Deviation)
 48.83  (8.93)   44.45  (6.34)   46.8  (8.00) 
Capillary Blood pO2 
[Units: mmHg]
Mean (Standard Deviation)
 37.77  (7.03)   37.00  (8.80)   37.42  (7.72) 
Capillary Blood HCO3 
[Units: mmol/L]
Mean (Standard Deviation)
 24.20  (3.45)   21.62  (9.34)   23.02  (6.78) 

  Outcome Measures

1.  Primary:   Peak Inspiratory Pressure   [ Time Frame: four hours ]

2.  Secondary:   Mean Airway Pressure   [ Time Frame: four hours ]

3.  Secondary:   Minute Ventilation   [ Time Frame: four hours ]

4.  Secondary:   Expiratory Tidal Volume   [ Time Frame: four hours ]

5.  Secondary:   Dynamic Compliance   [ Time Frame: four hours ]

6.  Secondary:   Work of Breathing   [ Time Frame: four hours ]

7.  Secondary:   Peak EAdi   [ Time Frame: four hours ]

8.  Secondary:   Fraction of Oxygen   [ Time Frame: four hours ]

9.  Secondary:   Capillary Blood pH   [ Time Frame: four hours ]

10.  Secondary:   Capillary Blood pCO2   [ Time Frame: four hours ]

11.  Secondary:   Capillary Blood pO2   [ Time Frame: four hours ]

12.  Secondary:   Capillary Blood HCO3   [ Time Frame: four hours ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Two patients were excluded prior to the study and five patients were interrupted the study because of a developed exclusion criterion during the protocol. Because of eliminated participants, the number of subjects analyzed was reduced.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Juyoung Lee
Organization: Seoul National University Hospital

Responsible Party: Han-Suk Kim, Seoul National University Hospital Identifier: NCT01389882     History of Changes
Other Study ID Numbers: VENT-01-NAVA
First Submitted: July 1, 2011
First Posted: July 8, 2011
Results First Submitted: September 18, 2011
Results First Posted: October 28, 2011
Last Update Posted: January 9, 2012