How NAVA Works in Preterm Infants With Irregular Respiratory Efforts

NCT04659083 | Completed

• 1 other identifier: NAVA-Turku01
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• the amount of backup breaths by the ventilator

  % time of backup/min according to babies' weight, postmenstrual age and postnatal age

  during the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age

Interventions

Neurally adjusted ventilatory assist ventilation mode DEVICE

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.

Eligibility Criteria

• Age: 0 Days - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

We included preterm infants born before 36 weeks of gestation who received at least 24 hours of ventilatory support with invasive or non-invasive NAVA using a Servo-i or Servo-n ventilator (Getinge, Gothenburg, Sweden).

You may qualify if:

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

You may not qualify if:

• babies using anesthetic agents

Sponsors & Collaborators

• Inha University Hospital: lead
• Turku University Hospital: collaborator

Study Sites (1)

Turku University Hospital Neonatal Intensive Care Unit

Turku, Finland

Location

Related Publications (1)

• 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.

  PMID: 34310871 DERIVED

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)