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

NCT01156467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-06-11

No results posted yet for this study

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.

Conditions

  • Ventilation

Interventions

DEVICE

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

Treatment with Edi-catheter

DEVICE

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.

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Timo Saarela, MD, PhD · Oulu University Hospital

  • Merja Ålander, MD · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01156467 on ClinicalTrials.gov