Neonatal Respiratory Distress Syndrome, Prematurity
Conditions
Keywords
Preterm Infant, Respiratory Distress Syndrome, Non-invasive respiratory Support, Neurally Adjust Respiratory Assist (NAVA), Nasal Intermittent Positive Pressure Ventilation
Brief summary
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.
Detailed description
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.
Interventions
OTHERRespiratory support: NAVA -NIV and PC-NIV
The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order
Sponsors
Politecnico di Milano
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in breath-by-breath variability of tidal breathing amplitude | over the last 30 minutes of each step (crossover trial, 2 steps, 1 hour-step) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate | 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 | Respiratory rate (breaths/min) will be recorded from the ventilator |
| Inspiratory Time | 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 (msec) will be recorded from the ventilator tracing |
| Duty Cycle | 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 (Inspiratory Time/ Total Time), will be calculated from the ventilator tracing |
| Total Respiratory System Oscillatory Resistance | at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step) | 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 | at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step) | 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). |
| Rate of apneas, desaturations, bradycardias | over 1 hour, for each step (in a 2-step crossover trial, 1-hour step) | Episodes of apnoeas, desaturations, bradycardias will be recorded over each study period |
| Rate of patient-ventilator asynchronies | over 1 hour, for each step (in a 2-step crossover trial, 1-hour step) | 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 |
| SpO2/FiO2 (Fraction on inspired oxygen) | 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 | 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, Transcutaneous Carbon Dioxide Partial Pressure (mmHg) | 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 | tpCO2 will be monitrored continuously over the study period and recorded at specific time points |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's comfort: COMFORT-B scale | at the end of each 1-hour step | Patient's comfort will be assessed by the attending nurse at the end of each step by means of the COMFORT-B scale (COMFORT behavioural scale). The COMFORT-B scale is a validated tool for assessing patients' comfort in Pediatric Intensive Care Unit.It includes the following items for comfort evaluation: alertness, calmness, respiratory response, cry, physical movements, muscle tone, facial tension. For each item a descriptive scale form 1 (the best) to 5 (the worst) is indicated and the operator can choose what is the most appropriate for the patient. |
| Number of caregivers interventions required | at the end of each 1-hour step | The number of interventions required to the attending personnel during each step will be also recorded: for instance interventions to improve comfort, to adjust the ventilator interface, to optimize the efficacy of respiratory support, suctioning ... |
Countries
Italy
Outcome results
None listed