{
  "FullStudy":{
    "Rank":218160,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511952",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NICU Music Tx Interventions"
          },
          "Organization":{
            "OrgFullName":"Beth Israel Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants",
          "OfficialTitle":"A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2007"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2010",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2010",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 16, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 19, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 24, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Beth Israel Medical Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a multi-site study of 272 premature infants >32 weeks who served in a randomized investigation (in morning or afternoon) where they served as their own controls. The infants' HR, RR, O2sats were measured with and without the implementation fo live music. The live interventions included songs of kin, selected by parents, the gato box and ocean disc played through entrained methods by a music therapist. The infants were evaluated within a two week period and in total each day including feeds, voids, activity level and sleep."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Prematurity",
              "Sepsis",
              "SGA",
              "RDS"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "music therapy",
              "entrainment",
              "premature infants",
              "live music intervention",
              "parent preferred lullabies"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"272",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Music intervention- SGA",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Music Intervention",
                    "Other: Music"
                  ]
                }
              },{
                "ArmGroupLabel":"Music Intervention- RDS",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Music Intervention",
                    "Other: Music"
                  ]
                }
              },{
                "ArmGroupLabel":"Music Intervention- Sepsis",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Infants randomly assigned to receive one of three interventions-randomized for the AM or PM",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Music Intervention",
                    "Other: Music"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Music Intervention",
                "InterventionDescription":"Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Music Intervention- RDS",
                    "Music Intervention- Sepsis",
                    "Music intervention- SGA"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Music",
                "InterventionDescription":"Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Music Intervention- RDS",
                    "Music Intervention- Sepsis",
                    "Music intervention- SGA"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Remo Ocean disc",
                    "Gato box",
                    "Music therapist's or Parent's preferred lullaby or 'Twinkle'"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"The effects of live music intervention on premature baby function",
                "PrimaryOutcomeDescription":"Infants function according to flow sheet and in cumulative administration will be viewed with and without music therapy entrainment",
                "PrimaryOutcomeTimeFrame":"over two weeks intervention periods"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Vitals",
                "SecondaryOutcomeDescription":"The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured",
                "SecondaryOutcomeTimeFrame":"10 mins before, during and after intervention"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPremature infants diagnosed with SGA, RDS and/or Sepsis >32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing\n\nExclusion Criteria:\n\nInfants with diagnoses other than the above",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"32 Weeks",
          "MaximumAge":"40 Weeks",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Joanne V Loewy, DA, MT-BC, LCAT",
                "OverallOfficialAffiliation":"Beth Israel Medical Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          }
        }
      },
      "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",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M19448",
                "ConditionBrowseLeafName":"Sepsis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15452",
                "ConditionBrowseLeafName":"Toxemia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "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"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}