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

NCT ID: NCT02770976

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-03-09

Brief Summary

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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

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Conditions

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Respiratory Distress Syndrome In Premature Infants Preterm Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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NAVA

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.

Group Type EXPERIMENTAL

Increasing and decreasing NAVA levels with 10-min intervals

Intervention Type DEVICE

Interventions

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Increasing and decreasing NAVA levels with 10-min intervals

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inha University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inha University Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

References

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Nam SK, Lee J, Jun YH. Neural feedback is insufficient in preterm infants during neurally adjusted ventilatory assist. Pediatr Pulmonol. 2019 Aug;54(8):1277-1283. doi: 10.1002/ppul.24352. Epub 2019 May 11.

Reference Type DERIVED
PMID: 31077579 (View on PubMed)

Other Identifiers

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NAVA-03-INV

Identifier Type: -

Identifier Source: org_study_id

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