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OpenTrials
Completed

NCT Number: NCT04659083

How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi, measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup breaths for each minute. All the ventilator data will be inspected and compared with the event logs recorded automatically from the ventilator, which includes all the alarm notification, mode and setting changes, cables connection and disconnection data. Data during disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded from the analysis. The mean values during each day will be computed for each ventilatory variables. If there is a change in the ventilatory setting parameters, we will choose the one which was applied for longer duration in the 24-hour time period.

The following clinical characteristics will be collected from medical records: gestational age at birth, birth weight, gender, the time and amount of feeding, medication during the study days, desaturation events, bradycardia events, suction time and methods.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • babies who receiving respiratory support with neurally adjusted ventilatory assist
  • babies with informed consents from their parents

Exclusion criteria

  • babies using anesthetic agents

Treatment and study plan

Neurally adjusted ventilatory assist ventilation mode

Device

This technique uses the electrical activity of the diaphragm (Edi) to control respiratory support and the NAVA level as an amplification factor that converts the Edi signal into a proportional pressure.

Primary outcomes

  1. the amount of backup breaths by the ventilator

    Time frame: during the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age

    % time of backup/min according to babies' weight, postmenstrual age and postnatal age

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Collaborators

  • Turku University Hospital

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2020
Registry last updated
Jan 12, 2021

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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