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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventilation

Intervention / Treatment
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* Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
* Device: Control group, ventilation with i-Servo or Stephanie


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 9 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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<br>* Ventilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used.<br>|
| Active Comparator: NAVA<br>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)<br>* Treatment with Edi-catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of mechanical ventilation |  | 1 hour - 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications associated to mechanical ventilation |  | 1 hour - 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurally adjusted ventilatory assist NAVA, Premature infant, Edi-signal