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

I

Inha University Hospital

Status

Completed

Conditions

Respiratory Distress Syndrome In Premature Infants
Preterm Infants

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02770976
NAVA-03-INV

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

NAVA
Experimental group
Description:
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.
Treatment:
Device: Increasing and decreasing NAVA levels with 10-min intervals

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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