{
  "FullStudy":{
    "Rank":217701,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517958",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GCO 11-0598"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"IF#1289354"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Icahn School of Medicine at Mount Sinai",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates",
          "OfficialTitle":"The Use of Lung Ultrasound to Diagnose RDS vs. TTN in Neonates Greater Than or Equal to 28 Weeks Gestation"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 24, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 25, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Icahn School of Medicine at Mount Sinai",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress.",
          "DetailedDescription":"Respiratory distress is a common reason for admission to the neonatal intensive care unit (NICU) for both preterm and full term newborns. TTN and RDS are the two most common diagnoses associated with respiratory distress. Due to their similar clinical presentations, it is often difficult to differentiate the two diseases clinically. Currently chest radiography is used to differentiate between TTN and RDS, however, radiographic findings are not always definitively diagnostic.\n\nIn preliminary studies, lung ultrasonography has been shown to be a useful tool in diagnosing both TTN and RDS. However, no one has looked at the use of lung ultrasonography in differentiating TTN from RDS in the neonatal population. We propose to do so in this study.\n\nPatients will be enrolled from neonatal admissions to the NICU with respiratory distress. Lung ultrasound will be performed on all enrolled subjects, looking for specific findings suggestive of either TTN or RDS. Data will be collected on gestational age, physical exam findings and level of respiratory support. Diagnoses will be recorded based on ultrasound findings. Accuracy of lung ultrasound diagnosis will be compared to that using radiographic chest radiography findings to evaluate if lung ultrasound is equivalent, or better than chest radiography in order to diagnose TTN versus RDS in this patient population."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Transient Tachypnea of the Newborn",
              "TTN",
              "Respiratory Distress Syndrome",
              "RDS"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Transient tachypnea of the newborn",
              "Respiratory Distress Syndrome",
              "Lung Ultrasound",
              "Neonates"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"No",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"36",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Respiratory Distress Group",
                "ArmGroupDescription":"Neonates 28 weeks GA or greater with respiratory distress",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Respiratory Distress Group"
                  ]
                }
              },{
                "ArmGroupLabel":"Control Group",
                "ArmGroupDescription":"Neonates 28 weeks GA or greater without respiratory distress.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Control Group"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Respiratory Distress Group",
                "InterventionDescription":"Diagnostic lung ultrasound.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Respiratory Distress Group"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Diagnostic lung ultrasound."
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Control Group",
                "InterventionDescription":"Lung ultrasound",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control Group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"lung ultrasound",
                "PrimaryOutcomeDescription":"The primary endpoint is to determine whether lung ultrasound is comparable or superior to chest radiography: (1) in making the diagnosis of RDS and TTN and (2) in differentiating between RDS and TTN.\n\nDisease-specific lung ultrasound findings: (1) Double lung point in TTN and (2) lung white-out in RDS.",
                "PrimaryOutcomeTimeFrame":"within first 24 hours of life."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\ngestational age ≥ 28 weeks\nsymptoms of respiratory distress defined as:\ntachypnea (respiratory rate > 60 breaths per minute)\nFiO2 requirement >21%\nintercostal/subcostal retractions\ngrunting and/or nasal flaring\nIf clinically warranted, a chest x-ray will be done as part of the workup for respiratory distress; these patients with CXR will be included in the study.\nInclusion criteria for the control group will be gestational age ≥ 28 weeks with no symptoms of respiratory distress (defined above).\n\nExclusion Criteria:\n\nneonates with prenatally diagnosed structural cardiac disease\nmajor multiple congenital anomalies\nother causes of respiratory distress that are not RDS or TTN (e.g. pneumothorax, CCAM or pneumonia).",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"28 Weeks",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Neonatal patients admitted to Mount Sinai NICU of gestational age greater than or equal to 28 weeks.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Ian Holzman, MD",
                "OverallOfficialAffiliation":"Icahn School of Medicine at Mount Sinai",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Icahn School of Medicine at Mount Sinai",
                "LocationCity":"New York",
                "LocationState":"New York",
                "LocationZip":"10029",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"No"
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012127",
                "ConditionMeshTerm":"Respiratory Distress Syndrome, Newborn"
              },{
                "ConditionMeshId":"D000012128",
                "ConditionMeshTerm":"Respiratory Distress Syndrome, Adult"
              },{
                "ConditionMeshId":"D000059246",
                "ConditionMeshTerm":"Tachypnea"
              },{
                "ConditionMeshId":"D000059245",
                "ConditionMeshTerm":"Transient Tachypnea of the Newborn"
              },{
                "ConditionMeshId":"D000013577",
                "ConditionMeshTerm":"Syndrome"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000004194",
                "ConditionAncestorTerm":"Disease"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000008171",
                "ConditionAncestorTerm":"Lung Diseases"
              },{
                "ConditionAncestorId":"D000012140",
                "ConditionAncestorTerm":"Respiratory Tract Diseases"
              },{
                "ConditionAncestorId":"D000012120",
                "ConditionAncestorTerm":"Respiration Disorders"
              },{
                "ConditionAncestorId":"D000007235",
                "ConditionAncestorTerm":"Infant, Premature, Diseases"
              },{
                "ConditionAncestorId":"D000007232",
                "ConditionAncestorTerm":"Infant, Newborn, Diseases"
              },{
                "ConditionAncestorId":"D000012818",
                "ConditionAncestorTerm":"Signs and Symptoms, Respiratory"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13547",
                "ConditionBrowseLeafName":"Respiratory Distress Syndrome, Newborn",
                "ConditionBrowseLeafAsFound":"Respiratory Distress Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13548",
                "ConditionBrowseLeafName":"Respiratory Distress Syndrome, Adult",
                "ConditionBrowseLeafAsFound":"Respiratory Distress Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14938",
                "ConditionBrowseLeafName":"Syndrome",
                "ConditionBrowseLeafAsFound":"Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M27998",
                "ConditionBrowseLeafName":"Tachypnea",
                "ConditionBrowseLeafAsFound":"Tachypnea",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M27997",
                "ConditionBrowseLeafName":"Transient Tachypnea of the Newborn",
                "ConditionBrowseLeafAsFound":"Transient Tachypnea of the Newborn",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M26731",
                "ConditionBrowseLeafName":"Acute Lung Injury",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9751",
                "ConditionBrowseLeafName":"Lung Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13560",
                "ConditionBrowseLeafName":"Respiratory Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13540",
                "ConditionBrowseLeafName":"Respiration Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24456",
                "ConditionBrowseLeafName":"Premature Birth",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8862",
                "ConditionBrowseLeafName":"Infant, Premature, Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8859",
                "ConditionBrowseLeafName":"Infant, Newborn, Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14206",
                "ConditionBrowseLeafName":"Signs and Symptoms, Respiratory",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4952",
                "ConditionBrowseLeafName":"Respiratory Distress Syndrome, Infant",
                "ConditionBrowseLeafAsFound":"Respiratory Distress Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T191",
                "ConditionBrowseLeafName":"Acute Respiratory Distress Syndrome",
                "ConditionBrowseLeafAsFound":"Respiratory Distress Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "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":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}