Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-22 @ 9:35 AM
Study NCT ID:
NCT01877720
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kimhans@snu.ac.kr', 'phone': '82-2-2072-1696', 'title': 'Dr. Han-Suk Kim', 'organization': 'Seoul National University College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NIV-PS', 'description': 'non-invasive PS', 'otherNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bradycardia', 'notes': 'Bradycardia longer than 2 min', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trigger Delay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '294.6', 'spread': '101.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ti_excess (Inspiratory Time in Excess)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '56.8', 'spread': '25.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'Ti\\_excess = (VPT-NIT)/NIT\n\nVPT: ventilator pressurization time (VPT) between beginning and end of inspiratory flow NIT: neural inspiratory time (NIT) between beginning of the increase in the diaphragmatic excitation and its maximal value', 'unitOfMeasure': 'percentage of neural inspiratory time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minute Ventilation Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '114.9', 'spread': '47.0', 'groupId': 'OG000'}, {'value': '124.1', 'spread': '42.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'inspiratory tidal volume / respiratory rate', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Inspiratory Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'last 5-min of each 15-min trial', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pneumatic Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'last 5-min of each 15-min trial', 'unitOfMeasure': 'breaths per min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum EAdi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'last 5-min of each 15-min trial', 'unitOfMeasure': 'uV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Swing EAdi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'last 5-min of each 15-min trial', 'unitOfMeasure': 'uV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Leakage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '87.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '86.7', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'last 5-min of each 15-min trial', 'description': '\\[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)\\]/TVi (inspiratory tidal volume)', 'unitOfMeasure': 'percentage of inspiratory tidal volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Asynchrony Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '11.5'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '38.1', 'upperLimit': '61.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'last 5-min of each 15-min trial', 'unitOfMeasure': 'events per min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asynchrony Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NIV-NAVA', 'description': 'non-invasive NAVA'}, {'id': 'OG001', 'title': 'NIV-PS', 'description': 'non-invasive PS'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '23.4'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '71.5', 'upperLimit': '78.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'total number of each event per minute\n\n1. ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization\n2. auto-triggering: a cycle delivered by the ventilator without EAdi signal\n3. premature cycling\n4. delayed cycling: VPT \\> NIT x2\n5. double triggering\n\n * Asynchrony index = \\[(1)+(2)+(3)+(4)+(5)\\]/\\[(1)+pneumatic respiratory rate\\] x100', 'unitOfMeasure': 'percentage of neural respiration', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SpO2', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'transcutaneous peripheral saturation of oxygen by pulse oximeter', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'timeFrame': 'last 5-min of each 15-min trial', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'systolic, diastolic and mean blood pressure measured by non-invasive cuff', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate', 'timeFrame': 'last 5-min of each 15-min trial', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PS-NAVA', 'description': 'noninvasive PSV first for 15 minutes and then NAVA for 15 minutes\n\ncrossover of noninvasive respiratory support with NAVA mode and PSV'}, {'id': 'FG001', 'title': 'NAVA-PS', 'description': 'noninvasive NAVA first for 15 minutes and then PSV for 15 minutes\n\ncrossover of noninvasive respiratory support with NAVA mode and PSV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': '1st Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': '2nd Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Enrolled Patients'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Gestational age', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'BG000', 'lowerLimit': '26.0', 'upperLimit': '28.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks of gestation', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Postnatal age at study', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '17.5', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'day', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth weight', 'classes': [{'categories': [{'measurements': [{'value': '790', 'groupId': 'BG000', 'lowerLimit': '675', 'upperLimit': '1215'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-18', 'studyFirstSubmitDate': '2013-06-05', 'resultsFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-18', 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trigger Delay', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.'}], 'secondaryOutcomes': [{'measure': 'Ti_excess (Inspiratory Time in Excess)', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'Ti\\_excess = (VPT-NIT)/NIT\n\nVPT: ventilator pressurization time (VPT) between beginning and end of inspiratory flow NIT: neural inspiratory time (NIT) between beginning of the increase in the diaphragmatic excitation and its maximal value'}, {'measure': 'Minute Ventilation Volume', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'inspiratory tidal volume / respiratory rate'}, {'measure': 'Peak Inspiratory Pressure', 'timeFrame': 'last 5-min of each 15-min trial'}, {'measure': 'Pneumatic Respiratory Rate', 'timeFrame': 'last 5-min of each 15-min trial'}, {'measure': 'Maximum EAdi', 'timeFrame': 'last 5-min of each 15-min trial'}, {'measure': 'Swing EAdi', 'timeFrame': 'last 5-min of each 15-min trial'}, {'measure': 'Leakage', 'timeFrame': 'last 5-min of each 15-min trial', 'description': '\\[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)\\]/TVi (inspiratory tidal volume)'}, {'measure': 'All Asynchrony Events', 'timeFrame': 'last 5-min of each 15-min trial'}, {'measure': 'Asynchrony Index', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'total number of each event per minute\n\n1. ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization\n2. auto-triggering: a cycle delivered by the ventilator without EAdi signal\n3. premature cycling\n4. delayed cycling: VPT \\> NIT x2\n5. double triggering\n\n * Asynchrony index = \\[(1)+(2)+(3)+(4)+(5)\\]/\\[(1)+pneumatic respiratory rate\\] x100'}, {'measure': 'SpO2', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'transcutaneous peripheral saturation of oxygen by pulse oximeter'}, {'measure': 'Heart Rate', 'timeFrame': 'last 5-min of each 15-min trial'}, {'measure': 'Blood Pressure', 'timeFrame': 'last 5-min of each 15-min trial', 'description': 'systolic, diastolic and mean blood pressure measured by non-invasive cuff'}, {'measure': 'Respiratory Rate', 'timeFrame': 'last 5-min of each 15-min trial'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preterm infant less than 32 weeks of gestation age', 'intubated more than 48 hours after birth', 'postextubation'], 'conditions': ['Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '26178463', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants less than 32 weeks of gestational age\n* intubated more than 48 hours after birth\n* subjected to extubation with minimal ventilator setting (mean airway pressure \\< 7cmH2O + peak inspiratory pressure \\< 13 cmH2O + FiO2 \\< 0.4 + respiratory rate \\< 35/min)\n* with informed consent from parents\n\nExclusion Criteria:\n\n* with major congenital anomalies\n* use of sedative or anesthetic drugs\n* hemodynamic instability\n* grade 3 or higher intraventricular hemorrhage\n* phrenic nerve palsy'}, 'identificationModule': {'nctId': 'NCT01877720', 'briefTitle': 'Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants', 'orgStudyIdInfo': {'id': 'NIV-NAVA Physiologic Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAVA-PS', 'description': 'noninvasive NAVA first for 15 minutes and then PSV for 15 minutes', 'interventionNames': ['Device: noninvasive respiratory support with NAVA mode and PSV']}, {'type': 'EXPERIMENTAL', 'label': 'PS-NAVA', 'description': 'noninvasive PSV first for 15 minutes and then NAVA for 15 minutes', 'interventionNames': ['Device: noninvasive respiratory support with NAVA mode and PSV']}], 'interventions': [{'name': 'noninvasive respiratory support with NAVA mode and PSV', 'type': 'DEVICE', 'armGroupLabels': ['NAVA-PS', 'PS-NAVA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Bundang', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital'}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul National University Children's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Han-Suk Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rotary', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Han-Suk Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}