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

Not Applicable

Completed

• Conditions: Preterm Infants; Respiratory Distress Syndrome In Premature Infants
• Interventions: Device: Increasing and decreasing NAVA levels with 10-min intervals

• Registration Number: NCT02770976
• Lead Sponsor: Inha University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Primary Completion: 2017-03-09
• Study Completion: 2017-03-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAVA	Increasing and decreasing NAVA levels with 10-min intervals	Seven increasing and decreasing NAVA levels (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 3.5, 3.0, 2.5, 2.0, 1.5, 1.0 and 0.5 cmH2O/uV) will applied to 20 preterm infants each for 10 minutes.

Primary Outcome Measures

Name	Time	Method
maximum Edi	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 Outcome Measures

Name	Time	Method
peak inspiratory pressure	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
tidal volume	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
electrical time product	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
inspiratory time in excess	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
comfort score	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

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of