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Reference values for the electrical activity of the diaphragm in neonates for use in neurally adjusted ventilation.

Neurally Adjusted Ventilatory Assist (NAVA) - Reference values for Electrical Activity of Diaphragm (Edi) in preterm and term neonates with no respiratory distress

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000907347
Acronym
NAVA REdi Study
Enrollment
32
Registered
2017-06-20
Start date
2017-04-13
Completion date
2017-08-24
Last updated
2017-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Neurally Adjusted Ventilatory Assist (NAVA) is a new ventilatory technique in neonates to aid babies with respiratory distress. It uses the baby's diaphragmatic electrical activity as a trigger for each breath. This electrical activity is measured using a special nasogastric tube (Edi catheter) with electrodes at the level of the diaphragm. To date, there is a little data on the Edi signal in neonates with no existing respiratory conditions and on no respiratory support. By gaining a reference Edi data range, clinicians will be better equipped to titrate NAVA levels in ventilated neonates. We hypothesise that Edi peak and Edi min were higher in (1) Higher gestational age group, (2) awake and postprandial states and (3) after caffeine administration (caffeine is only administered to those infants using the medication as part of their hospital treatment).

Interventions

Neonates, with no existing respiratory conditions and no respiratory support, who have a nasogastric tube in-situ for feeding purposes will be enrolled in the study. When these neonates are due for a tube change, an appropriately sized Edi catheter will be inserted instead and used as a feeding tube. The catheter will be connected to a Servo-n ventilator and the Edi signal will be recorded for 4 hours which is the duration of the study. After 4 hours, the catheter will be disconnected from the v

Neonates, with no existing respiratory conditions and no respiratory support, who have a nasogastric tube in-situ for feeding purposes will be enrolled in the study. When these neonates are due for a tube change, an appropriately sized Edi catheter will be inserted instead and used as a feeding tube. The catheter will be connected to a Servo-n ventilator and the Edi signal will be recorded for 4 hours which is the duration of the study. After 4 hours, the catheter will be disconnected from the ventilator and used as a standard feeding tube. Intervention adherence will be assessed by participating researchers, research nurse and nurse educators through regular communication with data collector. The project will also be discussed during regular research meetings.

Sponsors

Srinivas Bolisetty
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
0 to 30 Days
Healthy volunteers
No

Inclusion criteria

Neonates of 29-42 gestation age, no respiratory support or existing respiratory conditions, nasogastric feeding tube in-situ, informed parental consent

Exclusion criteria

Known congenital anomalies, infants with respiratory distress, major neurologic conditions and brain anomalies, neuromuscular diseases, apneas, conditions affecting innervation of diaphragm

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026