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Completed

NCT Number: NCT01156467

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

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.

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Key information

Conditions

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

Age range

Up to 9 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Oulu

Oulu, North Ostrobothnia, 90100, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Treatment with Edi-catheter

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.

Primary outcomes

  1. The duration of mechanical ventilation

    Time frame: 1 hour - 6 weeks

Secondary outcomes

  1. Complications associated to mechanical ventilation

    Time frame: 1 hour - 6 weeks

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 2, 2010
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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