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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 very low-birth-weight (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 1: Intervention group: The effect of intermittent phototherapy on very low birth weight infants. Intervention 2: Control group: The effect of continuous phototherapy in very low birth weight infants. Infants will be classified into high-risk and low-risk groups based on their intubation status and then randomly assigned to one of the two groups in a 1:1 ratio. The first group will receive continuous phototherapy and the other group will receive intermittent phototherapy for 15 minutes per hour. The infants' total serum bilirubin levels will be measured daily for seven days after birth and also on the day phototherapy is administered or stopped in the second week after birth. If more than one total serum bilirubin sample was taken per day, the total serum bilirubin level that was closest to 7 a.m. and the highest total serum bilirubin level of the day will both be recorded. The average total hours of phototherapy in the two groups will also be recorded and used for statistical comparison. Light-emitting diode phototherapy lamps will be used to emit narrow-spectrum blue light. The intensity of the phototherapy lamp will be preset so that patients receive 22 microwatts/cm2/nm of light at the low setting and 33 microwatts/cm2/nm at the high setting. The V-wave latency of the auditory brainstem evoked responses, a sensitive marker of bilirubin neurotoxicity, 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
Imam Highway
Kerman Iran (Islamic Republic of) 7616913355 031328000 z.jamali@kmu.ac.ir Kerman University of Medical Sciences scientific Zahran Jamali
Imam Highway
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 (GA: 28-32 wks) 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 P59.8 Neonatal jaundice from other specified causes Treatment - Devices Treatment - Devices Intervention group: The effect of intermittent phototherapy on very low birth weight infants. Control group: The effect of continuous phototherapy in very low birth weight infants. Infants will be classified into high-risk and low-risk groups based on their intubation status and then randomly assigned to one of the two groups in a 1:1 ratio. The first group will receive continuous phototherapy and the other group will receive intermittent phototherapy for 15 minutes per hour. The infants' total serum bilirubin levels will be measured daily for seven days after birth and also on the day phototherapy is administered or stopped in the second week after birth. If more than one total serum bilirubin sample was taken per day, the total serum bilirubin level that was closest to 7 a.m. and the highest total serum bilirubin level of the day will both be recorded. The average total hours of phototherapy in the two groups will also be recorded and used for statistical comparison. Light-emitting diode phototherapy lamps will be used to emit narrow-spectrum blue light. The intensity of the phototherapy lamp will be preset so that patients receive 22 microwatts/cm2/nm of light at the low setting and 33 microwatts/cm2/nm at the high setting. The V-wave latency of the auditory brainstem evoked responses, a sensitive marker of bilirubin neurotoxicity, is also measured. Neonatal jaundice rate. Timepoint: The primary outcomes were the mean peak TSB levels and total hours of phototherapy during the first 14 days of life. Method of measurement: Serum bilirubin levels. Kerman University of Medical Sciences Approved 2021-11-04 Kerman University of Medical Sciences Jahad Blvd., Ebn-e-Sina St., Kerman Kerman Iran (Islamic Republic of)