Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
Application of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants and Assessment of Its Benefits Compared to Synchronized Intermittent Mandatory Ventilation (SIMV) With Pressure Support (PS)
1 other identifier
interventional
26
1 country
1
Brief Summary
The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
October 28, 2011
CompletedJanuary 9, 2012
January 1, 2012
5 months
July 1, 2011
September 18, 2011
January 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak Inspiratory Pressure
peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode
four hours
Secondary Outcomes (11)
Mean Airway Pressure
four hours
Minute Ventilation
four hours
Expiratory Tidal Volume
four hours
Dynamic Compliance
four hours
Work of Breathing
four hours
- +6 more secondary outcomes
Study Arms (1)
ventilator assist
EXPERIMENTALInterventions
Neurally adjusted ventilatory assist (NAVA) utilizes the electrical activity of the diaphragm (EAdi) to trigger and cycle-off breaths, and therefore presents a means of bypassing the ventilator circuit, and the inherent delays with pneumatic triggering. This is a processed signal, which is not artificially influenced by changes in muscle length, chest wall configuration, and/or lung volume. It represents the summation of muscle motor unit recruitment and/or firing rate, and correlates with phrenic nerve activity. In this mode, the amount of support pressure is coupled with the magnitude of the EAdi. The proportion of support pressure to EAdi (NAVA level) is adjustable.
Eligibility Criteria
You may qualify if:
- preterm infants mechanically ventilated
- ventilatory set frequency is under 25
- with informed consent of their parents
You may not qualify if:
- major congenital anomalies
- patients without self respiratory effort
- use of sedative or anesthetic drugs
- grade III or IV intraventricular hemorrhage
- phrenic nerve palsy or insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Children's Hospital
Seoul, 110-733, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Juyoung Lee
- Organization
- Seoul National University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Han Suk Kim, Ph.D
Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist Professor
Study Record Dates
First Submitted
July 1, 2011
First Posted
July 8, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 9, 2012
Results First Posted
October 28, 2011
Record last verified: 2012-01