How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

Mechanical Ventilation Clinical Trial

Official title:

How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659083
• Other study ID #: NAVA-Turku01
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Mechanical Ventilation
• Neurally Adjusted Ventilatory Assist
• Premature Infants
• Ventilator Lung; Newborn

Intervention

Device:
• Neurally adjusted ventilatory assist ventilation mode
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.

Locations

Country	Name	City	State
Finland	Turku University Hospital Neonatal Intensive Care Unit	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Inha University Hospital	Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the amount of backup breaths by the ventilator	% time of backup/min according to babies' weight, postmenstrual age and postnatal age	during the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age