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Use of NAVA in Intubated Preterm

This study has been withdrawn prior to enrollment.
(Another institution performed the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536445
First Posted: September 27, 2007
Last Update Posted: June 1, 2016
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.
Information provided by:
Sunnybrook Health Sciences Centre
  Purpose
The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in neonates by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating a premature baby on NAVA with the Servoi for 12 hours.

Condition Intervention Phase
Infant, Premature Respiration, Artificial Device: NAVA Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Use of Neurally Adjusted Ventilatory Assist (NAVA) in an Intubated Premature Infant: A Case Control Study on the Servoi Ventilator

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • • Patient-ventilator synchrony (trigger delays, cycling-off delays) • Phasic electrical activity of the diaphragm EAdi • Tonic EAdi • tidal volume, airway pressure, respiratory rate • Oxygen saturation, transcutaneous CO2, FIO2 [ Time Frame: end of the 12 hour trial ]

Secondary Outcome Measures:
  • • Number of times back-up rate started (per hour) • Number of PEEP or NAVA level adjustments [ Time Frame: end of the 12 hour trial ]

Enrollment: 0
Study Start Date: October 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NAVA
    Neurally Adjusted Ventilatory Assist (mechanical ventilation controlled by the diaphragm electrical activity)
    Other Name: Servoi (Maquet Critical Care AB)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm newborn (>1 day postnatal age, gestational age >23 weeks, birth weight <1250g), intubated and mechanically ventilated, and breathing spontaneously, as defined by the ability to trigger the ventilator. The infant should be breathing on conventional ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: assist control/pressure support < 22 cm H2O, PEEP 4-6 cm H2O Fi02<.30

Exclusion Criteria:

  • Pneumothorax, degenerative neuromuscular disease, bleeding disorders, cardiovascular instability, cyanotic congenital cardiovascular disease, phrenic nerve damage/diaphragm paralysis, esophageal perforation, use of high frequency oscillatory or jet ventilation, contraindication to changing NG tube, or if infant is deemed "too unstable" by the clinical team. The use of narcotics is an exclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536445


Locations
Canada, Ontario
NICU, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M5S1B6
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Michael Dunn, MD Sunnybrook Health Sciences Centre
Principal Investigator: Jennifer Beck, PhD Sunnybrook Health Sciences Centre
  More Information

Publications:
Responsible Party: Dr Michael Dunn, SHSC
ClinicalTrials.gov Identifier: NCT00536445     History of Changes
Other Study ID Numbers: 124-2007
First Submitted: September 25, 2007
First Posted: September 27, 2007
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by Sunnybrook Health Sciences Centre:
NAVA
Preterm
Case study

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications