{
  "FullStudy":{
    "Rank":217979,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514331",
          "OrgStudyIdInfo":{
            "OrgStudyId":"01/2011-68"
          },
          "Organization":{
            "OrgFullName":"Gazi University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Ventilatory Parameters and Inflammatory Responses of Neonates Ventilated by Different Modes of Ventilation",
          "OfficialTitle":"Determination of Ventilatory Parameters and Inflammatory Responses of Neonates Who Are Ventilated by Volume Guarantee Combined With Synchronized Intermittent Mandatory Ventilation or Pressure Support Ventilation"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 20, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 19, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 20, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Ebru Ergenekon",
            "ResponsiblePartyInvestigatorTitle":"Prof.Dr",
            "ResponsiblePartyInvestigatorAffiliation":"Gazi University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Gazi University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in neonates.",
          "DetailedDescription":"Term or preterm neonates may need mechanical ventilation due to different etiologies. In all patients aim of mechanical ventilation is to promote pulmonary gas exchange, reduce the respiratory work of patient. Ideal mechanical ventilation must minimize pulmonary trauma with low inspiratory pressures that obtains adequate and constant tidal volumes. Ventilation associated pulmonary injury is an important subject that must be considered during mechanical ventilation. Atelectotrauma, volutrauma, barotrauma and biotrauma must be monitored. Volutrauma, barotrauma and oxygen toxicity cause cytokine increase that results in biotrauma. This parenchymal inflammation is a risk factor for chronic lung disease which is an important morbidity of ventilated neonates.\n\nFrom past to present neonates were ventilated with different ventilation modes including IMV (Intermittent Mandatory Ventilation), SIMV, A/C (Assist Control Ventilation), PSV,HFV (High Frequency Ventilation). Both PSV and SIMV are patient trigger ventilation modes but SIMV is a time cycled and PSV is a flow cycled mode. In recent years hybrid techniques were developed to combine beneficial features of volume and pressure limited ventilation. In commercial ventilation devices these techniques have different names as volume guaranteed pressure limited ventilation (Drager Babylog 8000), pressure regulated volume controlled ventilation (Siemens servo 3000), volume guaranteed pressure support ventilation (VIP Bird Gold).\n\nSince there is not a standard protocol for mechanical ventilation of neonates different countries and even different NICU's use different ventilation protocols.\n\nLiterature supports volume targetted ventilation to reduce barotrauma with low maximum inspiratory pressures and to reduce volutrauma with constant tidal volumes. When A/C+VG and SIMV+VG were compared in a crossover trial, more constant tidal volumes were obtained in A/C mode. Inflammatory cytokines have also been measured in different groups of patients with variable ventilatory management techniques. So far there has not been a randomized study published comparing VG+SIMV with VG+PSV in newborns with regards to tidal volume , peak inspiratory pressure variability,or inflammatory cytokines. Therefore in this study the investigators aimed to compare these two ventilation modes with regards to short term outcome."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Respiratory Distress, Newborn",
              "Ventilator Induced Lung Injury"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Ventilator Induced Lung Injury",
              "Neonatal respiratory distress",
              "Mechanical ventilation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"PSV+VG",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Neonates who require mechanical ventilation and randomised to pressure support + volume guarantee (PSV+VG) mode",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: PSV+VG (pressure support ventilation+volume guarantee)"
                  ]
                }
              },{
                "ArmGroupLabel":"SIMV+VG",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Neonates who require mechanical ventilation and randomised to synchronised intermittant mandatory ventilation + volume guarantee (SIMV+VG) mode",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)",
                "InterventionDescription":"Neonates who need mechanical ventilation will be ventilated with SIMV+VG mode",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "SIMV+VG"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "SIMV + VG mode of ventilation"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"PSV+VG (pressure support ventilation+volume guarantee)",
                "InterventionDescription":"Neonates who need mechanical ventilation will be ventilated with PSV+VG",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PSV+VG"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "PSV+ VG mode of ventilation"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"IL-1beta levels in tracheal aspirate material",
                "PrimaryOutcomeDescription":"Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported",
                "PrimaryOutcomeTimeFrame":"Baseline and 72 hours of mechanical ventilation"
              },{
                "PrimaryOutcomeMeasure":"IL-6 level in tracheal aspirate",
                "PrimaryOutcomeDescription":"Tracheal aspirate will be analyzed for IL6 level and the change from baseline will be reported",
                "PrimaryOutcomeTimeFrame":"Baseline and 72 hours of mechanical ventilation"
              },{
                "PrimaryOutcomeMeasure":"IL-8 in tracheal aspirate material",
                "PrimaryOutcomeDescription":"Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported",
                "PrimaryOutcomeTimeFrame":"Baseline and 72 hours of mechanical ventilation"
              },{
                "PrimaryOutcomeMeasure":"IL-10 level in tracheal aspirate material",
                "PrimaryOutcomeDescription":"Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported",
                "PrimaryOutcomeTimeFrame":"Baseline and 72 hours of mechanical ventilation"
              },{
                "PrimaryOutcomeMeasure":"TNF alfa in tracheal aspirate material",
                "PrimaryOutcomeDescription":"Tracheal aspirate will be analyzed for the mediator level and change from baseline will be reported",
                "PrimaryOutcomeTimeFrame":"Baseline and 72 hours of mechanical ventilation"
              },{
                "PrimaryOutcomeMeasure":"tidal volume variability",
                "PrimaryOutcomeDescription":"variability in tidal volume measured with babyview program",
                "PrimaryOutcomeTimeFrame":"72 hours of mechanical ventilation or entire ventilation time if extubated earlier"
              },{
                "PrimaryOutcomeMeasure":"peak inspiratory pressure variability",
                "PrimaryOutcomeDescription":"variability in peak inspiratory pressure measured with babyview program",
                "PrimaryOutcomeTimeFrame":"72 hours of mechanical ventilation or entire ventilation time if extubated earlier"
              },{
                "PrimaryOutcomeMeasure":"respiratory rate variability",
                "PrimaryOutcomeDescription":"changes in respiratory rate, tacypnea rate",
                "PrimaryOutcomeTimeFrame":"72 hours of mechanical ventilation or entire ventilation time if extubated earlier"
              },{
                "PrimaryOutcomeMeasure":"oxygen saturation variability",
                "PrimaryOutcomeDescription":"changes in oxygen saturation, desaturation rate, hyperoxy rate",
                "PrimaryOutcomeTimeFrame":"72 hours of mechanical ventilation or entire ventilation time if extubated earlier"
              },{
                "PrimaryOutcomeMeasure":"lowest carbondioxide level (mmHg)",
                "PrimaryOutcomeDescription":"ratio of hypocarbic blood gases and least pCo2 level",
                "PrimaryOutcomeTimeFrame":"72 hours of mechanical ventilation or entire ventilation time if extubated earlier"
              },{
                "PrimaryOutcomeMeasure":"highest carbondioxide level (mmHg)",
                "PrimaryOutcomeDescription":"ratio of hypercarbic blood gases and highest pCo2 level",
                "PrimaryOutcomeTimeFrame":"72 hours of mechanical ventilation or entire ventilation time if extubated earlier"
              },{
                "PrimaryOutcomeMeasure":"lowest oxygen level (mmHg)",
                "PrimaryOutcomeDescription":"ratio of hypoxic blood gases and least pO2 level",
                "PrimaryOutcomeTimeFrame":"72 hours of mechanical ventilation or entire ventilation time if extubated earlier"
              },{
                "PrimaryOutcomeMeasure":"highest oxygen level (mmHg)",
                "PrimaryOutcomeDescription":"ratio of hyperoxic blood gases and highest pO2 level",
                "PrimaryOutcomeTimeFrame":"72 hours of mechanical ventilation or entire ventilation time if extubated earlier"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"bronchopulmonary dysplasia",
                "SecondaryOutcomeDescription":"Oxygen requirement at 36 weeks corrected age",
                "SecondaryOutcomeTimeFrame":"36 weeks corrected age"
              },{
                "SecondaryOutcomeMeasure":"patent ductus arteriosus",
                "SecondaryOutcomeDescription":"Presence of hemodynamically significant patent ductus arteriosus in the first 7 days of life",
                "SecondaryOutcomeTimeFrame":"in the first week of post natal life of the patient"
              },{
                "SecondaryOutcomeMeasure":"necrotizing enterocolitis",
                "SecondaryOutcomeDescription":"Necrotising entercolitis defined by clinical and radiological findings",
                "SecondaryOutcomeTimeFrame":"36 weeks corrected age"
              },{
                "SecondaryOutcomeMeasure":"intraventricular hemorrhage",
                "SecondaryOutcomeDescription":"Intraventricular hemorrhage diagnosed by head ultrasound",
                "SecondaryOutcomeTimeFrame":"during first week"
              },{
                "SecondaryOutcomeMeasure":"pneumothorax",
                "SecondaryOutcomeDescription":"Air leak diagnosed by chest x-ray",
                "SecondaryOutcomeTimeFrame":"during first 3 days"
              },{
                "SecondaryOutcomeMeasure":"pulmonary interstitial emphysema",
                "SecondaryOutcomeDescription":"Air leak diagnosed by x-ray",
                "SecondaryOutcomeTimeFrame":"during first week"
              },{
                "SecondaryOutcomeMeasure":"pulmonary hemorrhage",
                "SecondaryOutcomeTimeFrame":"during first week"
              },{
                "SecondaryOutcomeMeasure":"retinopathy of prematurity",
                "SecondaryOutcomeDescription":"Retinal disease diagnosed by indirect opthtalmoscopic exam",
                "SecondaryOutcomeTimeFrame":"until 36 weeks corrected age"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nneonates with respiratory distress who need mechanical ventilation\ngestational age less than or equal to 37 weeks\nneonates who need mechanical ventilation within first 24 hours\n\nExclusion Criteria:\n\nneonates who need mechanical ventilation other than conventional ventilation",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MaximumAge":"24 Hours",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Ebru N Ergenekon, MD",
                "OverallOfficialAffiliation":"Gazi University, Division of newborn Medicine",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Gazi University Hospital, Department of Pediatrics, Division of Newborn Medicine",
                "LocationCity":"Besevler",
                "LocationState":"Ankara",
                "LocationZip":"06500",
                "LocationCountry":"Turkey"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000055370",
                "ConditionMeshTerm":"Lung Injury"
              },{
                "ConditionMeshId":"D000055397",
                "ConditionMeshTerm":"Ventilator-Induced Lung Injury"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000008171",
                "ConditionAncestorTerm":"Lung Diseases"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000013898",
                "ConditionAncestorTerm":"Thoracic Injuries"
              },{
                "ConditionAncestorId":"D000014947",
                "ConditionAncestorTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13547",
                "ConditionBrowseLeafName":"Respiratory Distress Syndrome, Newborn",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M26730",
                "ConditionBrowseLeafName":"Lung Injury",
                "ConditionBrowseLeafAsFound":"Lung Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M26739",
                "ConditionBrowseLeafName":"Ventilator-Induced Lung Injury",
                "ConditionBrowseLeafAsFound":"Ventilator-Induced Lung Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9751",
                "ConditionBrowseLeafName":"Lung Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15240",
                "ConditionBrowseLeafName":"Thoracic Injuries",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4952",
                "ConditionBrowseLeafName":"Respiratory Distress Syndrome, Infant",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC08",
                "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC16",
                "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}