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

University of Oulu

Status: Completed

Conditions: Ventilation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01156467

EETTMK:26/2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 9 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control

Active Comparator group

Description:

Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done.

Treatment:

Device: Control group, ventilation with i-Servo or Stephanie

NAVA

Active Comparator group

Description:

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.

Treatment:

Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)