The current study is a crossover trial, aiming at evaluating the effect of NAVA -NIV
compared to Nasal Intermittent Positive Pressure Ventilation (PC-NIV) at the same level
of peak inspiratory pressure, in terms of: breath-by-breath variability of tidal
breathing amplitude, variability of the other breathing patterns; lung mechanics; gas
exchange; rate of episodes of apnea; bradycardia and desaturations; respiratory
asynchrony and comfort, in preterm infants < 37+0 weeks+days post-menstrual age.

Breathing Variability and NAVA in Neonates

Neonatal Respiratory Distress Syndrome

Prematurity

Preterm infants matching the inclusion criteria (listed elsewhere) will be enrolled in a
cross- over trial of two modes of non-invasive respiratory support: nasal intermittent
positive pressure ventilation (PC-NIV) and NAVA NIV (Sevo-n Neonatal Ventilator, GETINGE,
Solna, Sweden). Parental consent will be collected prior to the study. A 20-minute
registration of ventilator parameters during assistance on NAVA-NIV will allow
calculating the mean PIP (peak inspiratory pressure), in order to compare the two modes
at the same level of PIP. The ventilator settings other than PIP (i.e. FiO2 (fraction of
inspired oxygen), PEEP (positive end-expiratory pressure), IT (inspiratory time), RR
(respiratory rate), NAVA level) will be based on the setting optimized by the attending
physicians prior to the study entry. FiO2 will be adjusted in order to maintain SpO2
88-93% in infants ≤ 32 weeks of postconceptional age, 90-95% in infants > 32 weeks of
postconceptional age. Infants will then receive a randomized sequence of 1-hour
assistance by NAVA NIV and 1-hour assistance PC-NIV or vice-versa. Infants will receive
respiratory support in a standardized supine position during the study period.

Two, high-resolution, small cameras will be placed in the infant's incubator to detect
chest and abdominal movements, by means of two markers placed on the infant's chest and
abdomen. Ventilators parameters (flow, pressure, volume, the electrical activity of the
diaphragm), vital signs (SpO2, HR (heart rate), ABP( arterial blood pressure)),
transcutaneous gases, changes in end-expiratory lung volume will be collected
continuously. Episodes of apnea, bradycardia or desaturations and the number of
interventions required by the nurses and the attending physicians during the study (e.g.
adjustment of the interface, suctioning, interventions to provide comfort or optimize the
respiratory support...) will be also collected during the study. Patients' comfort will
be assessed at the end of each sequence by the attending nurse by means of the COMFORT
scale. Lung mechanics will be measured at the end of each sequence by means of the Forced
Oscillation Technique.

Data will be then analysed and compared offline.

Respiratory support: NAVA -NIV and PC-NIV

Breathing Pattern Variability in Preterm Infants: Effect of Non-invasive Neurally Adjusted Ventilatory Assist (NAVA-NIV) Versus Nasal Intermittent Positive Pressure Ventilation (PC-NIV), a Crossover Study

Tidal breathing amplitude will be recorded continuously by mean of two, high-resolution
cameras placed inside the infant's incubator and skin (non-invasive) markers. Data will
be analysed a posteriori applying the DFA (Detrended Fluctuation Analysis) technique.

Principal Investigator

Respiratory rate (breaths/min) will be recorded from the ventilator

Inspiratory time (msec) will be recorded from the ventilator tracing

Duty Cycle (Inspiratory Time/ Total Time), will be calculated from the ventilator tracing

Total Respiratory System Oscillatory Resistance will be measured by the Forced
Oscillation Technique (FOT) at the end of each step, by superimposing to the ventilator
waveform an oscillatory pressure of small amplitude at 10 Hz (Fabian, ACUTRONIC Medical
Systems AG, Switzerland).

Total Respiratory System Oscillatory Reactance will be measured by the Forced Oscillation
Technique (FOT) at the end of each step, by superimposing to the ventilator waveform an
oscillatory pressure of small amplitude at 10 Hz (Fabian, ACUTRONIC Medical Systems AG,
Switzerland).

SpO2 and FiO2 will be monitored continuously and FiO2 will be adjusted to the target SpO2
88-93% in infants ≤ 32 weeks of postconceptional age, SpO2 90-95% in infants > 32 weeks
of postconceptional age.

tpCO2 will be monitrored continuously over the study period and recorded at specific time
points

Episodes of apnoeas, desaturations, bradycardias will be recorded over each study period

Patient-ventilator asynchronies will be calculated by continuous recording of ventilator
parameters (flow, pressure, volume and electrical diaphragmatic activity) and by
continuous recording of abdominal and chest movements by high resolution cameras placed
in the incubators and skin markers on abdomen and chest

All the infants enrolled in the study will receive 1 h of NAVA-NIV and 1h PC-NIV in a
cross-over study design

Breathing Variability and NAVA in Neonates

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status