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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01389882
First received: July 1, 2011
Last updated: January 5, 2012
Last verified: January 2012
Results First Received: September 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Condition: Infant, Preterm
Intervention: Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode

  Participant Flow
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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
  Description
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  
NOT COMPLETED     1     4  
Respiratory rate > 80/min during study                 1                 3  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  13     11     24  
Age  
[units: days]
Median ( Full Range )
  7  
  ( 2 to 57 )  
  5  
  ( 2 to 70 )  
  5  
  ( 2 to 70 )  
Gender  
[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 )
  990  
  ( 370 to 2510 )  
  1630  
  ( 710 to 2510 )  
  1075  
  ( 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 )
  1210  
  ( 670 to 2530 )  
  1530  
  ( 750 to 2580 )  
  1355  
  ( 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
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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
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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
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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
phone: lamb4122@snu.ac.kr
e-mail: lamb4122@snu.ac.kr


No publications provided


Responsible Party: Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01389882     History of Changes
Other Study ID Numbers: VENT-01-NAVA
Study First Received: July 1, 2011
Results First Received: September 18, 2011
Last Updated: January 5, 2012
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board