{
  "FullStudy":{
    "Rank":217985,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514253",
          "OrgStudyIdInfo":{
            "OrgStudyId":"SAOR 006.CTIL"
          },
          "Organization":{
            "OrgFullName":"The Baruch Padeh Medical Center, Poriya",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1",
          "OfficialTitle":"Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1",
          "Acronym":"glucose"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Not yet recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 5, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 20, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 23, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Shay Barak",
            "ResponsiblePartyInvestigatorTitle":"Senior Neonatologist, Neonatal Intensive Care",
            "ResponsiblePartyInvestigatorAffiliation":"The Baruch Padeh Medical Center, Poriya"
          },
          "LeadSponsor":{
            "LeadSponsorName":"The Baruch Padeh Medical Center, Poriya",
            "LeadSponsorClass":"OTHER_GOV"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.",
          "DetailedDescription":"During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.\n\nPain experienced during the neonatal period is known to have long term effects on the baby.\n\nThe red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Infant, Newborn, Diseases"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "glucose",
              "analgesic",
              "newborns"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Care Provider",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"180",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"glucose 25%",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"1 ml of glucose once",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Glucose 25%"
                  ]
                }
              },{
                "ArmGroupLabel":"infant formula",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Materna RTF stage 1",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Materna RTF Stage 1"
                  ]
                }
              },{
                "ArmGroupLabel":"Water for Injection",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Water for Injection"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Glucose 25%",
                "InterventionDescription":"1 ml glucose 25%, once",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "glucose 25%"
                  ]
                }
              },{
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Materna RTF Stage 1",
                "InterventionDescription":"1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "infant formula"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Materna RTF Phase 1"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Water for Injection",
                "InterventionDescription":"1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Water for Injection"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "WFI"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"less discomfort",
                "PrimaryOutcomeDescription":"the infant will experience less pain during examination",
                "PrimaryOutcomeTimeFrame":"immediate, during examination (day 1)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFull term above 37 weeks gestation.\nNormal birth-weight, healthy infants\nMales and Females\nWhose parents have signed the informed consent form\n\nExclusion Criteria:\n\nPremature born below 37 weeks\nChromosomal abnormalities or congenital malformation.\nSuffering neurological imbalance\nInability of oral feeding",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MaximumAge":"16 Days",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Shay Barak, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"04-6652328",
                "CentralContactEMail":"sbarak@poria.health.gov.il"
              },{
                "CentralContactName":"Robyn Rubin, Coordinator",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"04-6652328",
                "CentralContactEMail":"rrubin@poria.health.gov.il"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Shay Barak, MD",
                "OverallOfficialAffiliation":"The Baruch Pade Medical Center - Poriya",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Amir Kushnir, MD",
                "OverallOfficialAffiliation":"The Baruch Padeh Medical Center - Poria",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"NICU Department, The Baruch Padeh medical Center - Poriya",
                "LocationCity":"Tiberias",
                "LocationCountry":"Israel",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Shay Barak, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"04-6652328",
                      "LocationContactEMail":"sbarak@poria.health.gov.il"
                    },{
                      "LocationContactName":"Amir Kushnir, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Shay Barak, MD",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"Elena Chulsky, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Tatiana Dolgunova, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Natali Nikolski, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Natali Shaykevich, MD",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Orly Benor, RN,BSN.MsN",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Gilat Yeganeh, LLB,LLM, RN",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Maryanne Nabso, RN,MA",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Sijal Hlehel, RN,MA",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007232",
                "ConditionMeshTerm":"Infant, Newborn, Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8859",
                "ConditionBrowseLeafName":"Infant, Newborn, Diseases",
                "ConditionBrowseLeafAsFound":"Infant, Newborn, Diseases",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC16",
                "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}