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IRCT20191111045400N3 IRCT 2023-07-29 Bojnourd University of Medical Sciences Comparison of performance of phototherapy inside the incubator with conventional phototherapy method Comparison of performance of phototherapy inside the incubator with conventional phototherapy method in bilirubin of babies less than 1500gr 2023-09-23 anticipated 50 Complete https://irct.ir/trial/70733 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Babies were divided into two groups using a random method based on flip the coin method. Group 1: treatment with conventional methods (control group) Group 2: treatment with photo therapy inside the incubator (intervention group), Blinding description: The analyzer is not aware of the groups under study in analyzing the results. N/A Hyperbilirubinemia. Intervention 1: Intervention group: Phototherapy inside the incubator. One photo-therapy unit is placed above the head of the baby's bed (as usual) and the other unit is placed inside the incubator and at its lower end for 24 hours. Intervention 2: Control group:In the control group (conventional method), one photo-therapy unit is placed above the head of the baby's bed and another photo-therapy unit is placed along the width of the baby's bed for 24 hours. Yes - There is a plan to make this available What will be shared: Only laboratory results and research results can be shared When: beggining of year 2024 To whom: just for reaserchers Conditions: no conditions required Where to obtain: to the phone number inserted How to obtain: almost one week Comments:
public Mohamad Aamin Younessi
Imam Ali Hospital, Daneshgah Ave
bojnurd Iran (Islamic Republic of) 74877-94149 +98 58 3151 1423 a.younessi7@gmail.com Bojnourd University of Medical Sciences scientific Mohamad Amin Younessi
Imam Ali Hospital, Daneshgah Ave
Bojnurd Iran (Islamic Republic of) 74877-94149 +98 58 3151 1423 a.younessi@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Preterm babies Weight less than 1500 grams, age more than 24 hours, who were fed with breast milk or formula. Bilirubin levels based on gestational age or birth weight require photo-therapy. no limit 1 month Both Sick babies (infection, metabolic disease, hemolytic disease) The occurrence of jaundice in the first 24 hours of life, Receiving phenobarbital before and after delivery. Babies need blood transfusion R17.0 Hyperbilirubinaemia with mention of jaundice, not elsewhere classified Treatment - Devices Treatment - Devices Intervention group: Phototherapy inside the incubator. One photo-therapy unit is placed above the head of the baby's bed (as usual) and the other unit is placed inside the incubator and at its lower end for 24 hours. Control group:In the control group (conventional method), one photo-therapy unit is placed above the head of the baby's bed and another photo-therapy unit is placed along the width of the baby's bed for 24 hours. Total Bilirubin. Timepoint: Before the intervention, 8 hours after the intervention, 16 hours after the intervention and 24 hours after the intervention. Method of measurement: Biochemistry auto analyzer and colorimetric method. Bojnourd University of Medical Sciences Approved 2023-03-13 Ethics committee of North Khorasan University of Medical Sciences Ethics committee of North Khorasan University of Medical Sciences, Imam Ali Hospital, Daneshgah Ave Bojnurd North Khorasan Iran (Islamic Republic of)