Breathing Variability and NAVA in Neonates

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico25 enrolled

Overview

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.

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.

Study Type

Conditions

Neonatal Respiratory Distress Syndrome Prematurity

Interventions

Respiratory support: NAVA -NIV and PC-NIVOTHER

The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 Months

Medical Language ↔ Plain English

Inclusion Criteria: * preterm birth \< 37 weeks of gestational age * need of non-invasive respiratory support * parental consent Exclusion Criteria: * Major congenital abnormalities of the cardio-respiratory systems * Severe Respiratory Failure requiring intubation and mechanical ventilation at the time of the study; pH \< 7.25 pCO2\> 65 mmHg; pulmonary hypertension of the newborn requiring pharmacological treatment (Nitric Oxide, Sildenafil) * Hypoxic-Ischaemic Encephalopathy, neurological disorders which may compromise the integrity of the neural transmission from the brain to the diaphragm * Contraindication to orogastric tube insertion (e.g. oesophageal atresia, gastric perforation...) * Haemodynamic instability requiring inotropic agents * Any condition that would expose the patient to undue risk as deemed by the attending physician

Locations (1)

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

Outcomes

Primary Outcomes

Change in breath-by-breath variability of tidal breathing amplitude

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.

Time frame: over the last 30 minutes of each step (crossover trial, 2 steps, 1 hour-step)

Secondary Outcomes

Respiratory Rate

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

Time frame: at the beginning of the study, at 10minutes, 20minutes, 30minutes, 35minutes, 40minutes, 45minutes, 50minutes, 55minutes, for each step, in a 2-step crossover trial, 1-hour step

Inspiratory Time

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

Time frame: at the beginning of the study, at 10minutes, 20minutes, 30minutes, 35minutes, 40minutes, 45minutes, 50minutes, 55minutes, for each step, in a 2-step crossover trial, 1-hour step

Duty Cycle

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

Time frame: at the beginning of the study, at 10minutes, 20minutes, 30minutes, 35minutes, 40minutes, 45minutes, 50minutes, 55minutes, for each step, in a 2-step crossover trial, 1-hour step

Total Respiratory System Oscillatory Resistance

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).

Time frame: at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step)

Data from ClinicalTrials.gov

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