{
  "FullStudy":{
    "Rank":218062,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513226",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CH-160.7.002.920-3"
          },
          "Organization":{
            "OrgFullName":"University Children's Hospital, Zurich",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Cycled Light and Crying of Preterm Infants",
          "OfficialTitle":"Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2008",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2008",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 20, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Children's Hospital, Zurich",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Crying",
              "Sleep"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "cycled light",
              "dim light",
              "circadian rhythm",
              "actigraphy, sleep",
              "premature infant"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"37",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Dim light",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Day and nighttime dim light conditions",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Cycled light"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Cycled light",
                "InterventionDescription":"lights on at daytime, lights off at nighttime",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Dim light"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"mean duration and change over time for total duration per 24 hours for crying variables",
                "PrimaryOutcomeDescription":"mean duration per 24 hours for following variables: content, fussing, crying, unsoothable crying change over time, measured at 5 and 11 weeks corrected age\n\nmeasured by diary",
                "PrimaryOutcomeTimeFrame":"5 and 11 weeks corrected age"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"mean sleep duration per 24 hours and change over time",
                "SecondaryOutcomeDescription":"mean sleep duration per 24 hours measured by sleep diary measured at 5, 11 and 25 weeks corrected age, for adressing change over time",
                "SecondaryOutcomeTimeFrame":"5,11 and 25 weeks corrected age"
              },{
                "SecondaryOutcomeMeasure":"mean weight gain per day",
                "SecondaryOutcomeDescription":"mean weight gaing per day during hospital stay.",
                "SecondaryOutcomeTimeFrame":"during hospital stay"
              },{
                "SecondaryOutcomeMeasure":"mean activity count per 24 hours and change over time",
                "SecondaryOutcomeDescription":"mean activity count per 24 hours measured by actigraph recordings measured at three time points, 5, 11 and 25 weeks corrected age to adress change over time",
                "SecondaryOutcomeTimeFrame":"5, 11, and 25 weeks corrected age"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nvery preterm infants (≤ 32 0/7 weeks gestational age, GA)\n\nExclusion Criteria:\n\nmajor cerebral injuries such as intraventricular haemorrhage grade III (according to Papile 16) or periventricular leukomalacia or venous infarction (according to Govaert and de Vries 17) diagnosed by cranial ultrasound\nretinopathy of prematurity grade III and IV\ncongenital malformations\nsmall for gestational age (birth weight < 3rd percentile)\nprenatal infections\nintrauterine drug exposure",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Oskar Jenni, MD",
                "OverallOfficialAffiliation":"Children's Hospital Zurich",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25460255",
                "ReferenceType":"derived",
                "ReferenceCitation":"Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Very preterm infants show earlier emergence of 24-hour sleep-wake rhythms compared to term infants. Early Hum Dev. 2015 Jan;91(1):37-42. doi: 10.1016/j.earlhumdev.2014.11.002. Epub 2014 Nov 27."
              },{
                "ReferencePMID":"22689866",
                "ReferenceType":"derived",
                "ReferenceCitation":"Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Cycled light exposure reduces fussing and crying in very preterm infants. Pediatrics. 2012 Jul;130(1):e145-51. doi: 10.1542/peds.2011-2671. Epub 2012 Jun 11."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M24456",
                "ConditionBrowseLeafName":"Premature Birth",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}