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IRCT20211218053444N1 IRCT 2022-02-22 Kerman University of Medical Sciences Cycled phototherapy in treatment of neontal jaundice Comparison of cycled phototherapy with continuous phototherapy in treatment of jaundice in premature VLBW neonates 2022-03-05 anticipated 150 Complete https://irct.ir/trial/61949 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Infants will be Admitted to the Study by Observing the Inclusion Criteria, Which will be Classified into two Groups, High Risk and Low Risk, based on the State of Intubation, and then Will Be Randomly Divided into two Groups with a Ratio of 1: 1. the First Group will Receive Continuous Phototherapy and the Other Group Will Receive Periodic Phototherapy Beds for 15 Minutes Per Hour, Blinding description: Parents of infants participating in the study will be blinded in one of two groups after obtaining consent .Clinical caregivers are not blinded due to direct involvement with the baby and the need to discontinue phototherapy at the desired time. The researcher ,the assessor and the enlisor are blind in this study and extract the results from patient records. 1-2 Neonatal Jaundice. Intervention group: The effect of periodic phototherapy on VLBW neonates Control group: Effect of permanent phototherapy on VLBW neonates . Neonates will be classified into two groups of high risk and low risk based on intubation status and then randomly divided into two groups with a ratio of 1 to 1. The first group will undergo continuous phototherapy and the other group will be subjected to periodic phototherapy bed for 15 minutes per hour. Serum bilirubin total levels (TSB) of newborns will be measured daily for up to seven days after birth and also on the day that phototherapy was administered or stopped in the second week after birth. Also, the average total hours of phototherapy will be recorded in two groups and will be used for statistical comparison .Light-emitting diode phototherapy lamps will be used to irradiate the blue light of the narrow spectrum. The irradiance intensity of phototherapy lamp will be pre-adjusted so that patients receive 22 μW/cm2/nm of light in low settings equal to 33 μW/cm2/nm in high settings .V wave delay in Brainstem auditory-evoked responses (BAERs), a neurotoxicity sensitive marker with bilirubin, is also measured.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Information will be shared, but how it will be published will be announced later
public Zahra Jamali
Emam Blvd., Afzalipour Hospital
Kerman Iran (Islamic Republic of) 7616913355 031328000 z.jamali@kmu.ac.ir Kerman University of Medical Sciences scientific Zahran Jamali
Emam Blvd., Afzalipour Hospital
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8000 z.jamali@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Weight 1000 to 1500 grams Failure to receive previous phototherapy Need to receive phototherapy Age less than 24 hours 1 day 1 day Both Known hemolytic disease Asphyxia Non-bacterial infection overt Existence of major anomalies Unstable conditions (arterial blood pH less than 6.8 for more than 2 hours, stable bradycardia associated with hypoxia for more than 2 hours) Unwanted consent of the baby's parents or legal guardian to enter the study jaundice زردی نوزادان Treatment - Devices Intervention group: The effect of periodic phototherapy on VLBW neonates Control group: Effect of permanent phototherapy on VLBW neonates . Neonates will be classified into two groups of high risk and low risk based on intubation status and then randomly divided into two groups with a ratio of 1 to 1. The first group will undergo continuous phototherapy and the other group will be subjected to periodic phototherapy bed for 15 minutes per hour. Serum bilirubin total levels (TSB) of newborns will be measured daily for up to seven days after birth and also on the day that phototherapy was administered or stopped in the second week after birth. Also, the average total hours of phototherapy will be recorded in two groups and will be used for statistical comparison .Light-emitting diode phototherapy lamps will be used to irradiate the blue light of the narrow spectrum. The irradiance intensity of phototherapy lamp will be pre-adjusted so that patients receive 22 μW/cm2/nm of light in low settings equal to 33 μW/cm2/nm in high settings .V wave delay in Brainstem auditory-evoked responses (BAERs), a neurotoxicity sensitive marker with bilirubin, is also measured. Neonatal jaundice rate. Timepoint: Fourteen days. Method of measurement: Serum bilirubin levels. Kerman University of Medical Sciences Approved 2021-11-03 Kerman University of Medical Sciences Ebn-e-Sina St., Jahad Blvd., Kerman Kerman Kerman Iran (Islamic Republic of)