How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

NCT ID: NCT04659083

Last Updated: 2021-01-12

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

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-12-31

Brief Summary

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For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi, measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup breaths for each minute. All the ventilator data will be inspected and compared with the event logs recorded automatically from the ventilator, which includes all the alarm notification, mode and setting changes, cables connection and disconnection data. Data during disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded from the analysis. The mean values during each day will be computed for each ventilatory variables. If there is a change in the ventilatory setting parameters, we will choose the one which was applied for longer duration in the 24-hour time period.

The following clinical characteristics will be collected from medical records: gestational age at birth, birth weight, gender, the time and amount of feeding, medication during the study days, desaturation events, bradycardia events, suction time and methods.

Detailed Description

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Conditions

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Premature Infants Neurally Adjusted Ventilatory Assist Ventilator Lung; Newborn Mechanical Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Neurally adjusted ventilatory assist ventilation mode

This technique uses the electrical activity of the diaphragm (Edi) to control respiratory support and the NAVA level as an amplification factor that converts the Edi signal into a proportional pressure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* babies who receiving respiratory support with neurally adjusted ventilatory assist
* babies with informed consents from their parents

Exclusion Criteria

* babies using anesthetic agents
Minimum Eligible Age

0 Days

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

Inha University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Juyoung Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turku University Hospital Neonatal Intensive Care Unit

Turku, , Finland

Site Status

Countries

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Finland

References

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Lee J, Parikka V, Lehtonen L, Soukka H. Backup ventilation during neurally adjusted ventilatory assist in preterm infants. Pediatr Pulmonol. 2021 Oct;56(10):3342-3348. doi: 10.1002/ppul.25583. Epub 2021 Jul 26.

Reference Type DERIVED
PMID: 34310871 (View on PubMed)

Other Identifiers

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NAVA-Turku01

Identifier Type: -

Identifier Source: org_study_id

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