Skip to main content
OpenTrials
Completed

NCT Number: NCT02770976

Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants

This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal amplitude, work of breathing and comfort of preterm infants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Distress Syndrome in Premature Infants Preterm Infants

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inha University Hospital

Incheon, 22332, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • preterm infants born before 36 weeks of gestational age
  • who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress
  • no use of anesthetics or analgetics

Exclusion criteria

  • with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
  • with phrenic nerve palsy or injuries

Treatment and study plan

Increasing and decreasing NAVA levels with 10-min intervals

Device

Primary outcomes

  1. maximum Edi

    Time frame: the middle 2 minutes duration out of the total interval of 10 minutes

    mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period

Secondary outcomes

  1. comfort score

    Time frame: the 5-min point in the total 10-min period

    calculated score of premature infant pain profile (PIPP) from the recorded video, heart rates and oxygen saturation

  2. peak inspiratory pressure

    Time frame: the middle 2 minutes duration out of the total interval of 10 minutes

    mean of recorded peak inspiratory pressures in the middle 2 min duration out of the total 10 min period

  3. tidal volume

    Time frame: the middle 2 minutes duration out of the total interval of 10 minutes

    mean of recorded expiratory tidal volumes in the middle 2 min duration out of the total 10 min period

  4. inspiratory time in excess

    Time frame: the middle 2 minutes duration out of the total interval of 10 minutes

    mean of calculated excessive inspiratory times from the calculation ((ventilator pressurization time-neural inspiratory time)/neural inspiratory time) from the middle 2 min duration out of the total 10 min period

  5. electrical time product

    Time frame: the middle 2 minutes duration out of the total interval of 10 minutes

    mean of calculated electrical time product from the middle 2 min duration out of the total 10 min period

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 12, 2016
Registry last updated
Jan 26, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.