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

Preterm Infants Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770976
• Other study ID #: NAVA-03-INV
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: January 25, 2018
• Start date: May 2016
• Est. completion date: March 9, 2017

Study information

• Verified date: January 2018
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants
• Respiratory Distress Syndrome In Premature Infants
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Increasing and decreasing NAVA levels with 10-min intervals

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum Edi	mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period	the middle 2 minutes duration out of the total interval of 10 minutes
Secondary	comfort score	calculated score of premature infant pain profile (PIPP) from the recorded video, heart rates and oxygen saturation	the 5-min point in the total 10-min period
Secondary	peak inspiratory pressure	mean of recorded peak inspiratory pressures in the middle 2 min duration out of the total 10 min period	the middle 2 minutes duration out of the total interval of 10 minutes
Secondary	tidal volume	mean of recorded expiratory tidal volumes in the middle 2 min duration out of the total 10 min period	the middle 2 minutes duration out of the total interval of 10 minutes
Secondary	inspiratory time in excess	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	the middle 2 minutes duration out of the total interval of 10 minutes
Secondary	electrical time product	mean of calculated electrical time product from the middle 2 min duration out of the total 10 min period	the middle 2 minutes duration out of the total interval of 10 minutes