search
Back to results

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

Primary Purpose

Respiratory Distress Syndrome In Premature Infants, Preterm Infants

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Increasing and decreasing NAVA levels with 10-min intervals
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Distress Syndrome In Premature Infants

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inha University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAVA

Arm 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.

Outcomes

Primary Outcome Measures

maximum Edi
mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period

Secondary Outcome Measures

comfort score
calculated score of premature infant pain profile (PIPP) from the recorded video, heart rates and oxygen saturation
peak inspiratory pressure
mean of recorded peak inspiratory pressures in the middle 2 min duration out of the total 10 min period
tidal volume
mean of recorded expiratory tidal volumes in the middle 2 min duration out of the total 10 min period
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
electrical time product
mean of calculated electrical time product from the middle 2 min duration out of the total 10 min period

Full Information

First Posted
May 10, 2016
Last Updated
January 25, 2018
Sponsor
Inha University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02770976
Brief Title
Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 9, 2017 (Actual)
Study Completion Date
March 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inha University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome In Premature Infants, Preterm Infants

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAVA
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Increasing and decreasing NAVA levels with 10-min intervals
Primary Outcome Measure Information:
Title
maximum Edi
Description
mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period
Time Frame
the middle 2 minutes duration out of the total interval of 10 minutes
Secondary Outcome Measure Information:
Title
comfort score
Description
calculated score of premature infant pain profile (PIPP) from the recorded video, heart rates and oxygen saturation
Time Frame
the 5-min point in the total 10-min period
Title
peak inspiratory pressure
Description
mean of recorded peak inspiratory pressures in the middle 2 min duration out of the total 10 min period
Time Frame
the middle 2 minutes duration out of the total interval of 10 minutes
Title
tidal volume
Description
mean of recorded expiratory tidal volumes in the middle 2 min duration out of the total 10 min period
Time Frame
the middle 2 minutes duration out of the total interval of 10 minutes
Title
inspiratory time in excess
Description
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
Time Frame
the middle 2 minutes duration out of the total interval of 10 minutes
Title
electrical time product
Description
mean of calculated electrical time product from the middle 2 min duration out of the total 10 min period
Time Frame
the middle 2 minutes duration out of the total interval of 10 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31077579
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs