protocolSection identificationModule nctId: NCT06324799, orgStudyIdInfo id: 2023/51, briefTitle: The Effect of Position Change Frequency on Hyperbilirubinemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-07-14, completionDateStruct date: 2024-11-24, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, descriptionModule briefSummary: In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated.This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.Babies included in the study will be randomly divided into two groups by randomization method. While the babies in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours, the same procedure will be applied to the control group every 6 hours. All newborns included in the study were treated with the Unitest (Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at 50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the perineal area of the babies will be covered with a reduced diaper, and their eyes will be covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet rays. During phototherapy sessions, the total serum bilirubin level of the patient is checked; Phototherapy will be continued until it falls below the threshold value in the Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The descriptive characteristics of the babies included in the study and their total bilirubin and hematocrit values before the start of phototherapy will be recorded on the form prepared by the researchers. After phototherapy begins, position changes will be made every two hours for babies in the experimental group and every six hours for babies in the control group until the total serum bilirubin value falls below the phototherapy threshold value in the Bhutani nomogram.Bilirubin levels will be measured and recorded by venous measurement at the sixth hour and the 24th hour, and this process will be continued regularly until the bilirubin value decreases to the normal range. This practice is performed routinely in the clinic and will not be considered specific to the study., conditionsModule conditions: Newborn; Vitality, conditions: Hyperbilirubinemia, Neonatal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled clinical trial, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: phototherapy treatment, outcomesModule primaryOutcomes measure: Bhutani Nomogram, secondaryOutcomes measure: bilirubin level, secondaryOutcomes measure: hematocrit levels, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 15 Days, stdAges: CHILD, contactsLocationsModule locations facility: Tarsus State Hospital, status: RECRUITING, city: Mersin, country: Turkey, contacts name: Atiye Karakul, Ass. Prof., role: CONTACT, phone: 90(324) 600 00 33, phoneExt: 2231, email: atiyekarakul@gmail.com, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False