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NCT01156467 Clinical Trial

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

Ventilation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01156467
Other study ID # EETTMK:26/2010
Secondary ID
Status Completed
Phase N/A
First received July 1, 2010
Last updated June 10, 2013
Start date April 2010
Est. completion date June 2013

Study information
Verified date June 2013
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines AgencyFinland: Social and health ministryEuropean Union: Parliament of the European Union
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 9 Weeks
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with Edi-catheter
• 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.

Locations
Country Name City State
Finland University hospital of Oulu Oulu Pohjois-Pohjanmaa

Sponsors (1)
Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary The duration of mechanical ventilation 1 hour - 6 weeks No
Secondary Complications associated to mechanical ventilation 1 hour - 6 weeks No
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