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OpenTrials
Completed

NCT Number: NCT02048280

Comparing NAVA Levels in Intubated and Recently Extubated Neonates to Determine Optimal Non-invasive Ventilatory Support

Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount of support provided is determined in part by the NAVA level, where a higher NAVA level will provide higher level of support and unload more of the work of the diaphragm. The purpose of this study is to compare the optimal NAVA level in neonates while on mechanical ventilation while intubated and after being extubated.

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Key information

Conditions

Other Specified Respiratory Problems in Fetus or Neonate

Age range

23 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Promedica Toledo CHildren's Hospital NICU

Toledo, Ohio, 43606, United States

About this study

Baseline measurements will be taken. The NAVA titration study will then be done. The NAVA level will be set at a starting value of 0.1 cm H2O/mcV and systematically increased by 0.5 cm H2O/mcV every three minutes to a maximum of 3 cmH2O/mcV. Once the NAVA titration study has been completed, the patient will be extubated. There will be a stabilization period following extubation (15-30 minutes), and then the NAVA titration study will be repeated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neonates on NAVA ventilation

Exclusion criteria

-

Treatment and study plan

NAVA level

Procedure

Peak inspiratory pressure will be measured at each NAVA level

NAVA level

Other

Increase NAVA level every 3 minutes

Primary outcomes

  1. Changes in breakpoint in intubated and extubated patients

    Time frame: 20 minute study pre and post extubation

    NAVA titration study will be done pre and post extubation to determine and then compare the breakpoint.

Sponsors and collaborators

Lead sponsor

ProMedica Health System

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 29, 2014
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.