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

Not Applicable

Completed

• Conditions: Ventilation
• Interventions: Device: Control group, ventilation with i-Servo or Stephanie; Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)

• Registration Number: NCT01156467
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control group, ventilation with i-Servo or Stephanie	Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done.
NAVA	Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)	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.

Primary Outcome Measures

Name	Time	Method
The duration of mechanical ventilation	1 hour - 6 weeks

Secondary Outcome Measures

Name	Time	Method
Complications associated to mechanical ventilation	1 hour - 6 weeks

Trial Locations

Locations (1)

University hospital of Oulu; 🇫🇮 Oulu, Pohjois-Pohjanmaa, Finland