{
  "FullStudy":{
    "Rank":217948,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514747",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ISMRM_OU"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"ISMRM_2011",
                "SecondaryIdType":"Other Grant/Funding Number",
                "SecondaryIdDomain":"ISMRM Seed Grant"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Arkansas Children's Hospital Research Institute",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"A MRI Study of Visual and Motor Pathways in Premature Infants"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2018",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2018",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 11, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 12, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Arkansas Children's Hospital Research Institute",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the US. These babies often have motor and/or visual problems when they grow up. It is very important to identify high risk ELBW infants as early as possible, so that the investigators can treat them earlier to prevent poor development. Neurological examination at early age is not good enough to identify high risk ELBW infants. One the other hand, some magnetic resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at a very early age to predict long−term outcome and to identify infants who are at high risk of having motor and/or visual problems when they grow up."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Premature Birth"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"ELBW infants"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"MRI",
                "PrimaryOutcomeTimeFrame":"0"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nELBW infants with birth weight 401-1000 g (gestational age <30 weeks)\n\nExclusion Criteria:\n\nComplex congenital anomalies\nCentral nervous system malformations,\nChromosomal abnormalities, or hydrops fetalis",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"2 Months",
          "MaximumAge":"5 Months",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          },
          "StudyPopulation":"ELBW infants with birth weight 401-1000 g (gestational age <30 weeks)",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Arkansas Children's Hospital",
                "LocationCity":"Little Rock",
                "LocationState":"Arkansas",
                "LocationZip":"72211",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000047928",
                "ConditionMeshTerm":"Premature Birth"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000007752",
                "ConditionAncestorTerm":"Obstetric Labor, Premature"
              },{
                "ConditionAncestorId":"D000007744",
                "ConditionAncestorTerm":"Obstetric Labor Complications"
              },{
                "ConditionAncestorId":"D000011248",
                "ConditionAncestorTerm":"Pregnancy Complications"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M24456",
                "ConditionBrowseLeafName":"Premature Birth",
                "ConditionBrowseLeafAsFound":"Premature Birth",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9355",
                "ConditionBrowseLeafName":"Obstetric Labor, Premature",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9347",
                "ConditionBrowseLeafName":"Obstetric Labor Complications",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12710",
                "ConditionBrowseLeafName":"Pregnancy Complications",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}