Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-28 @ 6:33 PM
Study NCT ID:
NCT01727505
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2012-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nclaure@miami.edu', 'phone': '305 585 6408', 'title': 'Nelson Claure, MSc, PhD, Director Neonatal Pulmonary Research Lab', 'organization': 'University of Miami School of Medicine, Dept. of Pediatrics - Div. of Neonatology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Conventional Mechanical Ventilation Period', 'description': 'This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThese data represent the 24 hours of Conventional Mechanical Ventilation.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Volume Guarantee Ventilation Period', 'description': 'This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThese data represent the 24 hours of Volume Guarantee Ventilation.', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Increased PaCO2 requiring high frequency ventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Time Spent With Arterial Oxygen Saturation < 75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mechanical Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}, {'id': 'OG001', 'title': 'Volume Guarantee Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '6.9'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Percentage of time spent with arterial oxygen saturation \\< 75%', 'unitOfMeasure': '% of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Severe Hypoxemia Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mechanical Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}, {'id': 'OG001', 'title': 'Volume Guarantee Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '2.6'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '2.5'}]}]}], 'analyses': [{'pValue': '.75', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 \\< 75% lasting for at least 20 seconds.', 'unitOfMeasure': 'severe hypoxemia episodes per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Hypoxemia Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mechanical Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}, {'id': 'OG001', 'title': 'Volume Guarantee Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '7.9'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '8.9'}]}]}], 'analyses': [{'pValue': '0.2', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Frequency of hypoxemia episodes defined as episodes with arterial saturation \\< 85% for at least 20 seconds', 'unitOfMeasure': 'hypoxemia episodes per hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Hypoxemia Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mechanical Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}, {'id': 'OG001', 'title': 'Volume Guarantee Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '92'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '81'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Duration of hypoxemia episodes of arterial saturation \\< 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fraction of Inspired Oxygen (FiO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mechanical Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}, {'id': 'OG001', 'title': 'Volume Guarantee Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}], 'classes': [{'categories': [{'measurements': [{'value': '.42', 'groupId': 'OG000', 'lowerLimit': '.37', 'upperLimit': '.53'}, {'value': '.41', 'groupId': 'OG001', 'lowerLimit': '.36', 'upperLimit': '.46'}]}]}], 'analyses': [{'pValue': '.049', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Calculated as the mean value of the recorded fraction of inspired oxygen for each subject during each of the two 24 hour periods.\n\nReported as median and inter-quartile range of all subjects.', 'unitOfMeasure': 'fraction', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tidal Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mechanical Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}, {'id': 'OG001', 'title': 'Volume Guarantee Ventilation Period', 'description': 'This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.\n\nThe sequence of conventional and volume guarantee ventilation were assigned at random.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'The mean exhaled tidal volume of mechanical breaths.', 'unitOfMeasure': 'ml/Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence A: Conventional-Volume Guarantee', 'description': 'This is a crossover study. Each patient is randomly assigned to one of two sequences.\n\nSequence A consisted of a 24-hour period during which the infant received conventional mechanical ventilation followed by a 24 hour period during which the infant received volume guarantee ventilation.'}, {'id': 'FG001', 'title': 'Sequence B: Volume Guarantee-Conventional', 'description': 'This is a crossover study. Each patient is randomly assigned to one of two sequences.\n\nSequence B consisted of a 24-hour period during which the infant received volume guarantee ventilation followed by a 24 hour period during which the infant received conventional mechanical ventilation.'}], 'periods': [{'title': 'First 24 Hours', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second 24 Hours', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Missing data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at the Project NewBorn Neonatal Intensive Care Unit of the Jackson Memorial Hospital/University of Miami Medical Center. Subjects were recruited into the study between December, 2012 and September, 2014.', 'preAssignmentDetails': '42 infants were screened. Of these, 9 declined participation and 3 did not meet inclusion criteria.\n\n30 infants were enrolled (consented). Of these, 4 infants became ineligible after consent and were not studied.\n\n26 enrolled infants were studied.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Population', 'description': 'This is a crossover study. Infants were randomly assigned to one of two sequences.\n\nSequence A consisted of 24 hours of Conventional Mechanical Ventilation followed by 24 hours of Volume Guarantee Ventilation.\n\nSequence B consisted of 24 hours of Volume Guarantee Ventilation followed by 24 hours of Conventional Mechanical Ventilation.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Birth weight', 'classes': [{'categories': [{'measurements': [{'value': '685', 'spread': '216', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ventilator mandatory rate', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Peak inspiratory pressure', 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pressure support', 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Positive end expiratory pressure', 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '0.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fraction of Inspired Oxygen', 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '0.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'fraction', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2012-11-08', 'resultsFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2012-11-12', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-10', 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fraction of Inspired Oxygen (FiO2)', 'timeFrame': '24 hours', 'description': 'Calculated as the mean value of the recorded fraction of inspired oxygen for each subject during each of the two 24 hour periods.\n\nReported as median and inter-quartile range of all subjects.'}, {'measure': 'Tidal Volume', 'timeFrame': '24 hours', 'description': 'The mean exhaled tidal volume of mechanical breaths.'}], 'primaryOutcomes': [{'measure': 'Percentage of Time Spent With Arterial Oxygen Saturation < 75%', 'timeFrame': '24 hours', 'description': 'Percentage of time spent with arterial oxygen saturation \\< 75%'}], 'secondaryOutcomes': [{'measure': 'Frequency of Severe Hypoxemia Episodes', 'timeFrame': '24 hours', 'description': 'Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 \\< 75% lasting for at least 20 seconds.'}, {'measure': 'Frequency of Hypoxemia Episodes', 'timeFrame': '24 hours', 'description': 'Frequency of hypoxemia episodes defined as episodes with arterial saturation \\< 85% for at least 20 seconds'}, {'measure': 'Duration of Hypoxemia Episodes', 'timeFrame': '24 hours', 'description': 'Duration of hypoxemia episodes of arterial saturation \\< 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypoxemia', 'desaturation', 'mechanical ventilation', 'preterm infants', 'volume guarantee ventilation'], 'conditions': ['Episodic Hypoxemia in Mechanically Ventilated Preterm Infants']}, 'descriptionModule': {'briefSummary': 'Preterm infants undergoing mechanical ventilation often present with respiratory instability which leads to fluctuations in ventilation and oxygenation. In conventional modes of mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate and a constant peak inspiratory pressure.\n\nWe have demonstrated that spontaneous episodes of hypoxemia in mechanically ventilated preterm infants are frequently triggered by a loss in end-expiratory lung volume followed by decrease in tidal volume. This is due to a reduction in respiratory system compliance and increase in airway resistance.\n\nVolume Guarantee ventilation is a mode of ventilation in which ventilator measures the exhaled tidal volume of each ventilator breath and automatically adjusts the peak inspiratory pressure to deliver the set tidal volume. We have previously shown that Volume Guarantee reduced the severity and duration of hypoxemia episodes during a period of 2 hours in preterm infants The study hypothesis is that Volume Guarantee ventilation will decrease the duration of episodes of hypoxemia when compared to conventional mechanical ventilation during routine clinical conditions and over longer periods of time.\n\nThe objective of the study is to evaluate the effects of Volume Guarantee on the duration, severity and frequency of episodes of hypoxemia in mechanically ventilated preterm infants who present with frequent hypoxemia episodes in comparison to conventional ventilation over two periods of 24 hours each and under routine clinical conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born at less than 32 weeks of gestational age.\n* Requiring mechanical ventilation on a mandatory ventilator rate greater than or equal to 20 per minute and receiving a mean tidal volume of at least 4 ml/kg.\n* Presenting with 4 or more episodes of hypoxemia, defined as oxygen saturation less than 75%, in the 8 hours prior to the study.\n\nExclusion Criteria:\n\n* Major congenital anomalies.\n* Hemodynamic instability requiring inotropes within 72 hours prior to the study\n* Culture proven sepsis within 72 hours prior to the study.\n* Diagnosis of pulmonary interstitial emphysema or pneumothorax within the 72 hours prior to the study.'}, 'identificationModule': {'nctId': 'NCT01727505', 'briefTitle': 'Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Volume Guarantee Ventilation in Preterm Infants With Frequent Episodes of Hypoxemia', 'orgStudyIdInfo': {'id': '20120623'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence A: Conventional-Volume Guarantee', 'description': 'This is a crossover study. Infants will be assigned to one of two sequences. Sequence A consists of a 24-hour period during which the infant receives conventional mechanical ventilation followed by a second 24 hour period during which the infant receives volume guarantee ventilation.', 'interventionNames': ['Device: Sequence A: Conventional-Volume Guarantee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence B: Volume Guarantee-Conventional', 'description': 'This is a crossover study. Infants will be assigned to one of two sequences. Sequence B consists of a 24-hour period during which the infant receives volume guarantee ventilation followed by a second 24 hour period during which the infant receives conventional mechanical ventilation.', 'interventionNames': ['Device: Sequence B: Volume Guarantee-Conventional']}], 'interventions': [{'name': 'Sequence A: Conventional-Volume Guarantee', 'type': 'DEVICE', 'description': 'This is a crossover study. Infants will be randomly assigned to one of two sequences.\n\nIn sequence A, the infant will undergo a 24-hour period of conventional mechanical ventilation followed by a 24 hour period of volume guarantee ventilation.\n\nBoth conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).\n\nDuring the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.\n\nDuring volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study.', 'armGroupLabels': ['Sequence A: Conventional-Volume Guarantee']}, {'name': 'Sequence B: Volume Guarantee-Conventional', 'type': 'DEVICE', 'description': 'This is a crossover study. Infants will be randomly assigned to one of two sequences.\n\nIn sequence B, the infant will undergo a 24-hour period of volume guarantee ventilation followed by a 24 hour period of conventional mechanical ventilation.\n\nBoth conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).\n\nDuring the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.\n\nDuring volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study.', 'armGroupLabels': ['Sequence B: Volume Guarantee-Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Newborn Intensitve Care Unit at Holtz Children's Hospital of Jackson Health System", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Nelson Claure, M.Sc., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Eduardo Bancalari, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor of Pediatrics', 'investigatorFullName': 'Nelson Claure', 'investigatorAffiliation': 'University of Miami'}}}}