RecruitingACTRN12617000907347

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

Sponsor

Srinivas Bolisetty

Enrollment

32 participants

Start Date

Apr 13, 2017

Study Type

Interventional

Conditions

Neonatal respiratory distress

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).

Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 30 Dayss

Plain Language Summary

Simplified for easier understanding

This study is collecting reference measurements of the electrical signals from the diaphragm (the main breathing muscle) in healthy newborn babies who are not on any breathing support. These measurements come from a special feeding tube that detects how hard the baby's diaphragm is working. Having normal reference values will help doctors better calibrate ventilators for premature and sick newborns who need breathing support. You may be eligible if: - Your baby was born between 29 and 42 weeks of pregnancy - Your baby does not have any respiratory (breathing) conditions - Your baby already has a nasogastric feeding tube in place - You as the parent give informed consent You may NOT be eligible if: - Your baby has a known birth defect - Your baby has a breathing problem or respiratory distress - Your baby has a major brain or neurological condition - Your baby has a neuromuscular disease - Your baby has a condition affecting the nerve supply to the diaphragm Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.

Locations(1)

Royal Hospital for Women - Randwick

NSW, Australia

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