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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01156467

Enrollment

Registered

2010-07-02

Start date

2010-04-30

Completion date

2013-06-30

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation

Keywords

Neurally adjusted ventilatory assist NAVA, Premature infant, Edi-signal

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.

Interventions

DEVICENeurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)

Treatment with Edi-catheter

DEVICEControl 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 9 Weeks

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

Design outcomes

Primary

Measure	Time frame
The duration of mechanical ventilation	1 hour - 6 weeks

Secondary

Measure	Time frame
Complications associated to mechanical ventilation	1 hour - 6 weeks

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026