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Clinical Trials/NCT01156467
NCT01156467
Completed
N/A

Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants

University of Oulu1 site in 1 country60 target enrollmentApril 2010
ConditionsVentilation

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ventilation
Sponsor
University of Oulu
Enrollment
60
Locations
1
Primary Endpoint
The duration of mechanical ventilation
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA).

The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.

Detailed Description

Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs. In this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (NAVA). The aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merja Ålander

MD

University of Oulu

Eligibility Criteria

Inclusion Criteria

  • All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes

Exclusion Criteria

  • severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life
  • condition which prevents the positioning of an oro-/nasogastric tube

Outcomes

Primary Outcomes

The duration of mechanical ventilation

Time Frame: 1 hour - 6 weeks

Secondary Outcomes

  • Complications associated to mechanical ventilation(1 hour - 6 weeks)

Study Sites (1)

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