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IRCT20171218037936N3 IRCT 2020-03-07 Oroumia University of Medical Sciences The Effect of Intravenous Immunoglobulin on Jaundice The Effect of Intravenous Immunoglobulin on Jaundice Induced by Neonatal Isoimmune Hemolytic Disease 2019-03-22 anticipated 76 Complete https://irct.ir/trial/45773 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, all eligible patients were assigned to three groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes, Blinding description: In this study, clinical care giver and statistical analyzer were not aware of groups assigned to neonates. 3 Jaundice of neonates. Intervention 1: Intervention group 1: The first group (prophylaxis group) included the neonates who received IVIG at dose of 0.5 g / kg within 4 hours. IVIG used in the study had the trade name of Intratect manufactured by Biotest Company of Germany with 5% (50 g/l) solutions, each containing 50 mg immunoglobulin. Intervention 2: Intervention group 2:The second group (treatment group) included the neonates who received 0.5 g/kg of IVIG in the case of uncontrolled and progress of jaundice (hemodialysis) characterized by an increase in bilirubin number despite phototherapy and a decrease in hemoglobin, based on the Bhutani nomogram as approached the blood transfusion number (within the range of 3 gr / dl). Intervention 3: Control group: The third group (control group) included the neonates who received standard phototherapy (Intensive phototherapy). In case of lack of control of jaundice progression in the first and second groups, the second dose of IVIG was injected at the same dose of 0.5 g / kg 12 hours after the previous dose. Yes - There is a plan to make this available What will be shared: Any information without the need for patients' names will be available When: Six months after publication To whom: Faculty members Conditions: Email to Dr. Kamran Dehghan Where to obtain: Just email to Dr. Kamran Dehghan How to obtain: Just email to Dr. Kamran Dehghan Comments:
public Kamran Dehghan
No. 8, 2nd alley, Adalat Ave., orumieh city
Orumieh Iran (Islamic Republic of) 5714783734 +98 44 3365 4154 dehghan.k@umsu.ac.ir Oroumia University of Medical Sciences scientific Kamran Dehghan
No. 8, 2nd alley, Adalat Ave., orumieh city
Orumieh Iran (Islamic Republic of) 5714783734 +98 44 3365 4154 dehghan.k@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Neonates with Jaundice Informed consent of parents 1 day 30 days Both Neonates weighing less than 2500 grams P58.8 Neonatal jaundice due to other specified excessive hemolysis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: The first group (prophylaxis group) included the neonates who received IVIG at dose of 0.5 g / kg within 4 hours. IVIG used in the study had the trade name of Intratect manufactured by Biotest Company of Germany with 5% (50 g/l) solutions, each containing 50 mg immunoglobulin. Intervention group 2:The second group (treatment group) included the neonates who received 0.5 g/kg of IVIG in the case of uncontrolled and progress of jaundice (hemodialysis) characterized by an increase in bilirubin number despite phototherapy and a decrease in hemoglobin, based on the Bhutani nomogram as approached the blood transfusion number (within the range of 3 gr / dl). Control group: The third group (control group) included the neonates who received standard phototherapy (Intensive phototherapy). In case of lack of control of jaundice progression in the first and second groups, the second dose of IVIG was injected at the same dose of 0.5 g / kg 12 hours after the previous dose. Duration of hospitalization. Timepoint: Once on the time of discharge. Method of measurement: The length of time that the neonate is hospitalized. Duration of phototherapy. Timepoint: Once on the time of discharge. Method of measurement: Using a phototherapy machine. Plasmapheresis. Timepoint: Once on the time of discharge. Method of measurement: Based on file information. Bilirubin. Timepoint: Measured 4 times every 12 hours. Method of measurement: Blood sampling. Hemoglobin. Timepoint: Measured 4 times every 12 hours. Method of measurement: Blood sampling. Oroumia University of Medical Sciences Approved 2019-04-16 Ethics committee of Urmia University of Medical Sciences Urmia, Resalat Boulevard, Emergency alley Urmia West Azarbaijan Iran (Islamic Republic of)