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Use of NAVA in Intubated Preterm

This study has been withdrawn prior to enrollment.
(Another institution performed the study)
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00536445
First received: September 25, 2007
Last updated: July 27, 2011
Last verified: July 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1
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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 25, 2007
Last Updated: July 27, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 24, 2014