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CompletedNCT01056939Updated May 25, 2012

Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

An interventional study of Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) and Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden) in Ventilation, sponsored by University of Oulu. Completed at 1 site in Finland. Open to participants aged 1 Minute to 16 Years. Per ClinicalTrials.gov, last updated 2012-05-25.

Sponsored by University of Oulu · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
1 Minute to 16 Years
Sex
All
01

Study summary

The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not.

The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.

Read the detailed description

Asynchrony means that the timing of support given by ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.

In our study we randomly treat pediatric patients needing ventilatory support with neurally adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to find out if there are any special benefits for patients with each treatment mode.

02

Conditions studied

  • Ventilation

Keywords

  • Ventilatory care, children, intensive care, NAVA
  • Children needing ventilatory care
03

In context

Lead sponsor

University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes

Exclusion criteria

Exclusion Criteria:

  • Any condition that prevents feeding tube positioning. Critical ventilatory or perfusion problems.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (actual)

Study arms

  • Active comparator
    NAVA

    Children randomised in this arm will be treated with neurally adjusted ventilatory assist

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

  • Active comparator
    Control

    Patients randomized to control group will be treated with pressure controlled ventilation (PC) when they are newborns and older children in this group will be treated with pressure regulated volume controlled (PRVC) ventilation.

    Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)

Interventions

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

    Treatment with neurally adjusted ventilatory assist

  • DeviceControl (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)

    Treatment with PC or PRVC ventilation.

06

What researchers measure

Primary outcomes

  1. Primary outcome is the duration of mechanical ventilation

    Time frame: 30minutes-3weeks

Secondary outcomes

  1. Amount of sedative medication needed

    Time frame: 30minutes-3weeks

07

Study locations

1 site
  • University Hospital of Oulu
    Oulu, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01056939
Lead sponsor
University of Oulu
Responsible party
Merja Ålander (MD, University of Oulu) — Principal investigator
First posted
Jan 26, 2010
Start date
Sep 2009
Primary completion
May 2012
Completion
May 2012
Last update
May 25, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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