Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
Study NCT ID:
NCT04000568
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2019-05-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breathing Variability and NAVA in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-27', 'size': 208933, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-30T00:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Patient's comfort: COMFORT-B scale", 'timeFrame': 'at the end of each 1-hour step', 'description': "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."}, {'measure': 'Number of caregivers interventions required', 'timeFrame': 'at the end of each 1-hour step', 'description': '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 ...'}], 'primaryOutcomes': [{'measure': 'Change in breath-by-breath variability of tidal breathing amplitude', 'timeFrame': 'over the last 30 minutes of each step (crossover trial, 2 steps, 1 hour-step)', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Respiratory Rate', 'timeFrame': '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', 'description': 'Respiratory rate (breaths/min) will be recorded from the ventilator'}, {'measure': 'Inspiratory Time', 'timeFrame': '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', 'description': 'Inspiratory time (msec) will be recorded from the ventilator tracing'}, {'measure': 'Duty Cycle', 'timeFrame': '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', 'description': 'Duty Cycle (Inspiratory Time/ Total Time), will be calculated from the ventilator tracing'}, {'measure': 'Total Respiratory System Oscillatory Resistance', 'timeFrame': 'at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step)', 'description': '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).'}, {'measure': 'Total Respiratory System Oscillatory Reactance', 'timeFrame': 'at the end of each 1-hour step of the trial (crossover trial, 2 steps, 1 hour-step)', 'description': '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).'}, {'measure': 'SpO2/FiO2 (Fraction on inspired oxygen)', 'timeFrame': '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', 'description': '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.'}, {'measure': 'tpCO2, Transcutaneous Carbon Dioxide Partial Pressure (mmHg)', 'timeFrame': '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', 'description': 'tpCO2 will be monitrored continuously over the study period and recorded at specific time points'}, {'measure': 'Rate of apneas, desaturations, bradycardias', 'timeFrame': 'over 1 hour, for each step (in a 2-step crossover trial, 1-hour step)', 'description': 'Episodes of apnoeas, desaturations, bradycardias will be recorded over each study period'}, {'measure': 'Rate of patient-ventilator asynchronies', 'timeFrame': 'over 1 hour, for each step (in a 2-step crossover trial, 1-hour step)', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm Infant', 'Respiratory Distress Syndrome', 'Non-invasive respiratory Support', 'Neurally Adjust Respiratory Assist (NAVA)', 'Nasal Intermittent Positive Pressure Ventilation'], 'conditions': ['Neonatal Respiratory Distress Syndrome', 'Prematurity']}, 'referencesModule': {'references': [{'pmid': '11015506', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25621457', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '18562451', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28745986', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30343941', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23582965', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18272893', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20472939', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '12851212', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11818322', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16424726', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18339891', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22805999', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28690548', 'type': 'BACKGROUND', 'citation': 'Bartolak-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.'}, {'pmid': '19171062', 'type': 'BACKGROUND', 'citation': 'Arold SP, Malavia N, George SC. Mechanical compression attenuates normal human bronchial epithelial wound healing. Respir Res. 2009 Feb 12;10(1):9. doi: 10.1186/1465-9921-10-5.'}, {'pmid': '19136581', 'type': 'BACKGROUND', 'citation': 'Arold SP, Bartolak-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.'}, {'pmid': '24238745', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26899957', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27837754', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23100042', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25401284', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22481227', 'type': 'BACKGROUND', 'citation': 'de la Oliva P, Schuffelmann C, Gomez-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.'}, {'pmid': '28399118', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26178463', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25505779', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29910465', 'type': 'BACKGROUND', 'citation': 'Garcia-Munoz Rodrigo F, Urquia Marti L, Galan Henriquez G, Rivero Rodriguez S, Hernandez Gomez 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.'}, {'pmid': '29687665', 'type': 'BACKGROUND', 'citation': 'Zannin E, Veneroni C, Dellaca 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.'}, {'pmid': '11538314', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1063/1.166141.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nTwo, 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.\n\nData will be then analysed and compared offline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'preterm infants born \\< 37 weeks of gestation, requiring non-invasive respiratory support', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm birth \\< 37 weeks of gestational age\n* need of non-invasive respiratory support\n* parental consent\n\nExclusion Criteria:\n\n* Major congenital abnormalities of the cardio-respiratory systems\n* 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)\n* Hypoxic-Ischaemic Encephalopathy, neurological disorders which may compromise the integrity of the neural transmission from the brain to the diaphragm\n* Contraindication to orogastric tube insertion (e.g. oesophageal atresia, gastric perforation...)\n* Haemodynamic instability requiring inotropic agents\n* Any condition that would expose the patient to undue risk as deemed by the attending physician'}, 'identificationModule': {'nctId': 'NCT04000568', 'acronym': 'BRAVe NANO', 'briefTitle': 'Breathing Variability and NAVA in Neonates', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BRAVe NANO (NIV)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Population', 'description': 'All the infants enrolled in the study will receive 1 h of NAVA-NIV and 1h PC-NIV in a cross-over study design', 'interventionNames': ['Other: Respiratory support: NAVA -NIV and PC-NIV']}], 'interventions': [{'name': 'Respiratory support: NAVA -NIV and PC-NIV', 'type': 'OTHER', 'description': 'The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order', 'armGroupLabels': ['Study Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Anna Lavizzari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'at protocol submission', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'free'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'collaborators': [{'name': 'Politecnico di Milano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Lavizzari', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}