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| Name | Class |
|---|---|
| Politecnico di Milano | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Population | All the infants enrolled in the study will receive 1 h of NAVA-NIV and 1h PC-NIV in a cross-over study design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory support: NAVA -NIV and PC-NIV | Other | The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Inspiratory Time |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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preterm infants born < 37 weeks of gestation, requiring non-invasive respiratory support
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| Name | Affiliation | Role |
|---|---|---|
| Anna Lavizzari, MD | Fondazione IRCCS CÃ Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU, Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Milan | MI | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11015506 | Background | Costeloe K, Hennessy E, Gibson AT, Marlow N, Wilkinson AR. The EPICure study: outcomes to discharge from hospital for infants born at the threshold of viability. Pediatrics. 2000 Oct;106(4):659-71. doi: 10.1542/peds.106.4.659. | |
| 25621457 | Background | Ancel PY, Goffinet F; EPIPAGE-2 Writing Group; Kuhn P, Langer B, Matis J, Hernandorena X, Chabanier P, Joly-Pedespan L, Lecomte B, Vendittelli F, Dreyfus M, Guillois B, Burguet A, Sagot P, Sizun J, Beuchee A, Rouget F, Favreau A, Saliba E, Bednarek N, Morville P, Thiriez G, Marpeau L, Marret S, Kayem G, Durrmeyer X, Granier M, Baud O, Jarreau PH, Mitanchez D, Boileau P, Boulot P, Cambonie G, Daude H, Bedu A, Mons F, Fresson J, Vieux R, Alberge C, Arnaud C, Vayssiere C, Truffert P, Pierrat V, Subtil D, D'Ercole C, Gire C, Simeoni U, Bongain A, Sentilhes L, Roze JC, Gondry J, Leke A, Deiber M, Claris O, Picaud JC, Ego A, Debillon T, Poulichet A, Coline E, Favre A, Flechelles O, Samperiz S, Ramful D, Branger B, Benhammou V, Foix-L'Helias L, Marchand-Martin L, Kaminski M. Survival and morbidity of preterm children born at 22 through 34 weeks' gestation in France in 2011: results of the EPIPAGE-2 cohort study. JAMA Pediatr. 2015 Mar;169(3):230-8. doi: 10.1001/jamapediatrics.2014.3351. |
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the study protocol, statistical analysis plan an Informed Consent (only in the original language, available in English under request) will be available from the study protocol submission date. Analytic code status: still undecided.
at protocol submission
free
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2019 | May 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
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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 |
| 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 |
| 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) |
| 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) |
| 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 |
| 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 |
| 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) |
| 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) |
| at the end of each 1-hour step |
| 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 |
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| 28745986 | Background | Doyle LW, Carse E, Adams AM, Ranganathan S, Opie G, Cheong JLY; Victorian Infant Collaborative Study Group. Ventilation in Extremely Preterm Infants and Respiratory Function at 8 Years. N Engl J Med. 2017 Jul 27;377(4):329-337. doi: 10.1056/NEJMoa1700827. |
| 30343941 | Background | Dumpa V, Bhandari V. Surfactant, steroids and non-invasive ventilation in the prevention of BPD. Semin Perinatol. 2018 Nov;42(7):444-452. doi: 10.1053/j.semperi.2018.09.006. Epub 2018 Oct 2. |
| 23582965 | Background | Bhandari V. The potential of non-invasive ventilation to decrease BPD. Semin Perinatol. 2013 Apr;37(2):108-14. doi: 10.1053/j.semperi.2013.01.007. |
| 18272893 | Background | Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788. |
| 20472939 | Background | SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16. |
| 12851212 | Background | Arold SP, Suki B, Alencar AM, Lutchen KR, Ingenito EP. Variable ventilation induces endogenous surfactant release in normal guinea pigs. Am J Physiol Lung Cell Mol Physiol. 2003 Aug;285(2):L370-5. doi: 10.1152/ajplung.00036.2003. |
| 11818322 | Background | Arold SP, Mora R, Lutchen KR, Ingenito EP, Suki B. Variable tidal volume ventilation improves lung mechanics and gas exchange in a rodent model of acute lung injury. Am J Respir Crit Care Med. 2002 Feb 1;165(3):366-71. doi: 10.1164/ajrccm.165.3.2010155. |
| 16424726 | Background | Bellardine CL, Hoffman AM, Tsai L, Ingenito EP, Arold SP, Lutchen KR, Suki B. Comparison of variable and conventional ventilation in a sheep saline lavage lung injury model. Crit Care Med. 2006 Feb;34(2):439-45. doi: 10.1097/01.ccm.0000196208.01682.87. |
| 18339891 | Background | Thammanomai A, Hueser LE, Majumdar A, Bartolak-Suki E, Suki B. Design of a new variable-ventilation method optimized for lung recruitment in mice. J Appl Physiol (1985). 2008 May;104(5):1329-40. doi: 10.1152/japplphysiol.01002.2007. Epub 2008 Mar 13. |
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| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |