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Completed

NCT Number: NCT01624012

Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants

The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is better in noninvasive ventilation of premature infants than currently used Nasal Continuous Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.

The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more synchronous with patient, which will lead to a decrease in need of inspired oxygen.

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Key information

Conditions

Respiratory Distress Syndrome (RDS) of Neonate Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

1 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University hospital

Oulu, 90230, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • postconceptional age 28+0 - 36+6
  • need of ncpap treatment and inspired oxygen for at least 60 minutes

Exclusion criteria

  • severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy
  • any condition which prevents insertion of naso/orogastric tube

Treatment and study plan

NIV NAVA

Device

Non invasive ventilation with neurally adjusted ventilatory assist

nasal Continuous Positive Airway Pressure

Device

Noninvasive respiratory support with continuous positive airway pressure

Primary outcomes

  1. Duration of inspired oxygen supply

    Time frame: 30minutes- 3weeks

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary outcomes

  1. Duration of noninvasive ventilation

    Time frame: 30 minutes - 3 weeks

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  2. Fraction of inspired oxygen

    Time frame: 0, 1, 3 and 6hours, after which every 6 hours

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

  3. Blood gas analyses

    Time frame: 3 weeks

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.

  4. Duration of parenteral nutrition

    Time frame: 3 weeks

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants

Acronym: NIV NAVA

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jun 20, 2012
Registry last updated
May 12, 2016

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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