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

NCT01156467 | Completed

• 1 other identifier: EETTMK:26/2010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The duration of mechanical ventilation

  1 hour - 6 weeks

Secondary Outcomes (1)

• Complications associated to mechanical ventilation

  1 hour - 6 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

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

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

NAVA

ACTIVE COMPARATOR

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.

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

Interventions

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

Treatment with Edi-catheter

NAVA

Control group, ventilation with i-Servo or Stephanie DEVICE

Ventilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used.

Control

Eligibility Criteria

• Age: Up to 9 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

University hospital of Oulu

Oulu, North Ostrobothnia, 90100, Finland

Location

MeSH Terms

Conditions

Respiratory Aspiration; Premature Birth

Interventions

Interactive Ventilatory Support; Control Groups

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Timo Saarela, MD, PhD

  Oulu University Hospital

  STUDY DIRECTOR

• Merja Ålander, MD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

FI (1)