Prematurity Clinical Trial
— BRAVe NANOOfficial title:
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
Verified date | March 2023 |
Source | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | November 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 1 Day to 3 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | MI |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Politecnico di Milano |
Italy,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient's comfort: COMFORT-B scale | 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. | at the end of each 1-hour step | |
Other | Number of caregivers interventions required | 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 ... | at the end of each 1-hour step | |
Primary | 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. | over the last 30 minutes of each step (crossover trial, 2 steps, 1 hour-step) | |
Secondary | Respiratory Rate | Respiratory rate (breaths/min) will be recorded from the ventilator | 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 | |
Secondary | Inspiratory Time | Inspiratory time (msec) will be recorded from the ventilator tracing | 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 | |
Secondary | Duty Cycle | Duty Cycle (Inspiratory Time/ Total Time), will be calculated from the ventilator tracing | 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 | |
Secondary | 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). | at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step) | |
Secondary | Total Respiratory System Oscillatory Reactance | 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). | at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step) | |
Secondary | SpO2/FiO2 (Fraction on inspired oxygen) | 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. | 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 | |
Secondary | tpCO2, Transcutaneous Carbon Dioxide Partial Pressure (mmHg) | tpCO2 will be monitrored continuously over the study period and recorded at specific time points | 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 | |
Secondary | Rate of apneas, desaturations, bradycardias | Episodes of apnoeas, desaturations, bradycardias will be recorded over each study period | over 1 hour, for each step (in a 2-step crossover trial, 1-hour step) | |
Secondary | Rate of patient-ventilator asynchronies | 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 | over 1 hour, for each step (in a 2-step crossover trial, 1-hour step) |
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