Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
|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.|
|ClinicalTrials.gov Identifier: NCT01156467|
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : June 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventilation||Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) Device: Control group, ventilation with i-Servo or Stephanie||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: Control
Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done.
Device: Control group, ventilation with i-Servo or Stephanie
Ventilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used.
Active Comparator: NAVA
Infants randomised to this arm will receive and Edi-catheter as an oro-/nasogastric tube and the Edi-signal will be monitored and when possible NAVA-ventilation used.
Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with Edi-catheter
- The duration of mechanical ventilation [ Time Frame: 1 hour - 6 weeks ]
- Complications associated to mechanical ventilation [ Time Frame: 1 hour - 6 weeks ]
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): NCT01156467
|University hospital of Oulu|
|Oulu, Pohjois-Pohjanmaa, Finland, 90100|
|Study Director:||Timo Saarela, MD, PhD||Oulu University Hospital|
|Principal Investigator:||Merja Ålander, MD||Oulu University Hospital|