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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02770976
Enrollment
14
Registered
2016-05-12
Start date
2016-05-31
Completion date
2017-03-09
Last updated
2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants, Respiratory Distress Syndrome In Premature Infants

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.

Interventions

DEVICEIncreasing and decreasing NAVA levels with 10-min intervals

Sponsors

Inha University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
maximum Edithe middle 2 minutes duration out of the total interval of 10 minutesmean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period

Secondary

MeasureTime frameDescription
comfort scorethe 5-min point in the total 10-min periodcalculated score of premature infant pain profile (PIPP) from the recorded video, heart rates and oxygen saturation
peak inspiratory pressurethe middle 2 minutes duration out of the total interval of 10 minutesmean of recorded peak inspiratory pressures in the middle 2 min duration out of the total 10 min period
tidal volumethe middle 2 minutes duration out of the total interval of 10 minutesmean of recorded expiratory tidal volumes in the middle 2 min duration out of the total 10 min period
inspiratory time in excessthe middle 2 minutes duration out of the total interval of 10 minutesmean 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
electrical time productthe middle 2 minutes duration out of the total interval of 10 minutesmean of calculated electrical time product from the middle 2 min duration out of the total 10 min period

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026