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出境医 / 临床实验 / Breathing Variability and NAVA in Neonates (BRAVe NANO)

Breathing Variability and NAVA in Neonates (BRAVe NANO)

Study Description
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.

Condition or disease Intervention/treatment
Neonatal Respiratory Distress Syndrome Prematurity Other: Respiratory support: NAVA -NIV and PC-NIV

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.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official 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
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
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
 Other: Respiratory support: NAVA -NIV and PC-NIV
The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order
Outcome Measures
Primary Outcome Measures :
  1. Change in breath-by-breath variability of tidal breathing amplitude [ Time Frame: 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 Outcome Measures :
  1. Respiratory Rate [ 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 ]
    Respiratory rate (breaths/min) will be recorded from the ventilator

  2. Inspiratory Time [ 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 (msec) will be recorded from the ventilator tracing

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

  4. Total Respiratory System Oscillatory Resistance [ Time Frame: 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).

  5. Total Respiratory System Oscillatory Reactance [ Time Frame: 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).

  6. SpO2/FiO2 (Fraction on inspired oxygen) [ 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 ]
    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.

  7. tpCO2, Transcutaneous Carbon Dioxide Partial Pressure (mmHg) [ 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 ]
    tpCO2 will be monitrored continuously over the study period and recorded at specific time points

  8. Rate of apneas, desaturations, bradycardias [ Time Frame: 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

  9. Rate of patient-ventilator asynchronies [ Time Frame: 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


Other Outcome Measures:
  1. Patient's comfort: COMFORT-B scale [ Time Frame: 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.

  2. Number of caregivers interventions required [ Time Frame: 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 ...


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
preterm infants born < 37 weeks of gestation, requiring non-invasive respiratory support
Criteria

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
Contacts and Locations

Contacts
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Contact: Anna Lavizzari, MD +39 3208715095 anna.lavizzari@gmail.com
Contact: Mariarosa Colnaghi, MD +39 0255032234 mariarosa.colnaghi@mangiagalli.it

Locations
Layout table for location information
Italy
NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Recruiting
Milan, MI, Italy, 20122
Contact: Anna Lavizzari, MD    +39 3208715095    anna.lavizzari@gmail.com   
Contact: Mariarosa Colnaghi, MD    +39 02 5503 2234    mariarosa.colnaghi@mangiagalli.it   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Politecnico di Milano
Investigators
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Principal Investigator: Anna Lavizzari, MD Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
Tracking Information
First Submitted Date May 31, 2019
First Posted Date June 27, 2019
Last Update Posted Date July 29, 2020
Actual Study Start Date May 2, 2019
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2019) 		Change in breath-by-breath variability of tidal breathing amplitude [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2019)
  • Respiratory Rate [ 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 ]
    Respiratory rate (breaths/min) will be recorded from the ventilator
  • Inspiratory Time [ 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 (msec) will be recorded from the ventilator tracing
  • Duty Cycle [ 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 (Inspiratory Time/ Total Time), will be calculated from the ventilator tracing
  • Total Respiratory System Oscillatory Resistance [ Time Frame: 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 [ Time Frame: 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).
  • SpO2/FiO2 (Fraction on inspired oxygen) [ 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 ]
    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) [ 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 ]
    tpCO2 will be monitrored continuously over the study period and recorded at specific time points
  • Rate of apneas, desaturations, bradycardias [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2019)
  • Patient's comfort: COMFORT-B scale [ Time Frame: 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 [ Time Frame: 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 ...
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Breathing Variability and NAVA in Neonates
Official 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
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.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population preterm infants born < 37 weeks of gestation, requiring non-invasive respiratory support
Condition
  • Neonatal Respiratory Distress Syndrome
  • Prematurity
Intervention Other: Respiratory support: NAVA -NIV and PC-NIV
The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order
Study Groups/Cohorts 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
Intervention: Other: Respiratory support: NAVA -NIV and PC-NIV
Publications *
  • 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.
  • 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, Beuchée 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, Daudé H, Bédu A, Mons F, Fresson J, Vieux R, Alberge C, Arnaud C, Vayssière C, Truffert P, Pierrat V, Subtil D, D'Ercole C, Gire C, Simeoni U, Bongain A, Sentilhes L, Rozé JC, Gondry J, Leke A, Deiber M, Claris O, Picaud JC, Ego A, Debillon T, Poulichet A, Coliné E, Favre A, Fléchelles O, Samperiz S, Ramful D, Branger B, Benhammou V, Foix-L'Hélias 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. Erratum in: JAMA Pediatr. 2015 Apr;169(4):323. Alberge, Catherine [Corrected to Alberge, Corine].
  • Hennessy EM, Bracewell MA, Wood N, Wolke D, Costeloe K, Gibson A, Marlow N; EPICure Study Group. Respiratory health in pre-school and school age children following extremely preterm birth. Arch Dis Child. 2008 Dec;93(12):1037-43. doi: 10.1136/adc.2008.140830. Epub 2008 Jun 18.
  • 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.
  • 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. Review.
  • 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. Review.
  • 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. Erratum in: N Engl J Med. 2008 Apr 3;358(14):1529.
  • 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, Sánchez 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. Erratum in: N Engl J Med. 2010 Jun 10;362(23):2235.
  • 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.
  • 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.
  • 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.
  • Thammanomai A, Hueser LE, Majumdar A, Bartolák-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. Erratum in: J Appl Physiol. 2008 Jun;104(6):1856.
  • Berry CA, Suki B, Polglase GR, Pillow JJ. Variable ventilation enhances ventilation without exacerbating injury in preterm lambs with respiratory distress syndrome. Pediatr Res. 2012 Oct;72(4):384-92. doi: 10.1038/pr.2012.97. Epub 2012 Jul 17.
  • Bartolák-Suki E, Noble PB, Bou Jawde S, Pillow JJ, Suki B. Optimization of Variable Ventilation for Physiology, Immune Response and Surfactant Enhancement in Preterm Lambs. Front Physiol. 2017 Jun 23;8:425. doi: 10.3389/fphys.2017.00425. eCollection 2017.
  • Arold SP, Malavia N, George SC. Mechanical compression attenuates normal human bronchial epithelial wound healing. Respir Res. 2009 Feb 12;10:9. doi: 10.1186/1465-9921-10-5.
  • Arold SP, Bartolák-Suki E, Suki B. Variable stretch pattern enhances surfactant secretion in alveolar type II cells in culture. Am J Physiol Lung Cell Mol Physiol. 2009 Apr;296(4):L574-81. doi: 10.1152/ajplung.90454.2008. Epub 2009 Jan 9.
  • Stein H, Firestone K. Application of neurally adjusted ventilatory assist in neonates. Semin Fetal Neonatal Med. 2014 Feb;19(1):60-9. doi: 10.1016/j.siny.2013.09.005. Epub 2013 Nov 13. Review.
  • Stein H, Beck J, Dunn M. Non-invasive ventilation with neurally adjusted ventilatory assist in newborns. Semin Fetal Neonatal Med. 2016 Jun;21(3):154-61. doi: 10.1016/j.siny.2016.01.006. Epub 2016 Feb 16. Review.
  • Firestone KS, Beck J, Stein H. Neurally Adjusted Ventilatory Assist for Noninvasive Support in Neonates. Clin Perinatol. 2016 Dec;43(4):707-724. doi: 10.1016/j.clp.2016.07.007. Review.
  • Stein H, Alosh H, Ethington P, White DB. Prospective crossover comparison between NAVA and pressure control ventilation in premature neonates less than 1500 grams. J Perinatol. 2013 Jun;33(6):452-6. doi: 10.1038/jp.2012.136. Epub 2012 Oct 25.
  • Longhini F, Ferrero F, De Luca D, Cosi G, Alemani M, Colombo D, Cammarota G, Berni P, Conti G, Bona G, Della Corte F, Navalesi P. Neurally adjusted ventilatory assist in preterm neonates with acute respiratory failure. Neonatology. 2015;107(1):60-7. doi: 10.1159/000367886. Epub 2014 Nov 7.
  • de la Oliva P, Schüffelmann C, Gómez-Zamora A, Villar J, Kacmarek RM. Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial. Intensive Care Med. 2012 May;38(5):838-46. doi: 10.1007/s00134-012-2535-y. Epub 2012 Apr 6.
  • Gibu CK, Cheng PY, Ward RJ, Castro B, Heldt GP. Feasibility and physiological effects of noninvasive neurally adjusted ventilatory assist in preterm infants. Pediatr Res. 2017 Oct;82(4):650-657. doi: 10.1038/pr.2017.100. Epub 2017 Jul 12.
  • Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.
  • Baudin F, Wu HT, Bordessoule A, Beck J, Jouvet P, Frasch MG, Emeriaud G. Impact of ventilatory modes on the breathing variability in mechanically ventilated infants. Front Pediatr. 2014 Nov 25;2:132. doi: 10.3389/fped.2014.00132. eCollection 2014.
  • García-Muñoz Rodrigo F, Urquía Martí L, Galán Henríquez G, Rivero Rodríguez S, Hernández Gómez A. Neural breathing patterns in preterm newborns supported with non-invasive neurally adjusted ventilatory assist. J Perinatol. 2018 Sep;38(9):1235-1241. doi: 10.1038/s41372-018-0152-5. Epub 2018 Jun 18.
  • Zannin E, Veneroni C, Dellacà RL, Corbetta R, Suki B, Tagliabue PE, Ventura ML. Effect of continuous positive airway pressure on breathing variability in early preterm lung disease. Pediatr Pulmonol. 2018 Jun;53(6):755-761. doi: 10.1002/ppul.24017. Epub 2018 Apr 23.
  • Peng CK, Havlin S, Stanley HE, Goldberger AL. Quantification of scaling exponents and crossover phenomena in nonstationary heartbeat time series. Chaos. 1995;5(1):82-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2019) 		25
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Months   (Child)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Anna Lavizzari, MD +39 3208715095 anna.lavizzari@gmail.com
Contact: Mariarosa Colnaghi, MD +39 0255032234 mariarosa.colnaghi@mangiagalli.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04000568
Other Study ID Numbers BRAVe NANO (NIV)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: at protocol submission
Access Criteria: free
Responsible Party Anna Lavizzari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study Sponsor Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators Politecnico di Milano
Investigators
Principal Investigator: Anna Lavizzari, MD Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico
PRS Account Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Verification Date July 2020

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