Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 10, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2017
CompletedJanuary 26, 2018
January 1, 2018
10 months
May 10, 2016
January 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
maximum Edi
mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period
the middle 2 minutes duration out of the total interval of 10 minutes
Secondary Outcomes (5)
comfort score
the 5-min point in the total 10-min period
peak inspiratory pressure
the middle 2 minutes duration out of the total interval of 10 minutes
tidal volume
the middle 2 minutes duration out of the total interval of 10 minutes
inspiratory time in excess
the middle 2 minutes duration out of the total interval of 10 minutes
electrical time product
the middle 2 minutes duration out of the total interval of 10 minutes
Study Arms (1)
NAVA
EXPERIMENTALSeven 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
- with phrenic nerve palsy or injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inha University Hospital
Incheon, 22332, South Korea
Related Publications (1)
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.
PMID: 31077579DERIVED
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2016
First Posted
May 12, 2016
Study Start
May 1, 2016
Primary Completion
March 9, 2017
Study Completion
March 9, 2017
Last Updated
January 26, 2018
Record last verified: 2018-01