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IRCT20130313012803N3 IRCT 2023-12-02 Rasht University of Medical Sciences Investigation of the effect of oral ursodeoxycholic acid drug in neonatal jaundice Comparison of the effect of adding oral ursodeoxycholic acid to phototherapy and phototherapy alone on indirect hyperbilirubinemia in term infants with G6PDd and ABO and Rh incompatibility - a randomized controlled clinical trial study 2023-12-06 anticipated 106 Complete https://irct.ir/trial/73099 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done before the start of the program using the https://www.sealedenvelope.com software, considering 53 people in each 2 groups (Urso group, photo and phototherapy alone) in blocks of 4, and each of them are placed in a separate envelope according to the list obtained from the software and the envelope will be sealed and will be given to a third party. If the patient comes and is eligible, the envelope will be opened and according to the desired sequence, without knowing the next treatment, the patient is treated, Blinding description: The method of allocating children in two groups is based on quadruple random blocks. If the children meet the entry criteria, they will be placed in two groups A (Urso) and B (control). Before starting the study, this list is kept hidden in the children's research center in a sealed envelope. After starting the reading list, the children will be placed in two groups, A and B, that is, Ursu and control. Random allocation will be done by a third person who is unaware of the study and the groups, and the researchers will not be involved in this matter. 4 Infant hyperbilirubinemia. Intervention 1: Intervention group: 3 to 10-day term infants with indirect hyperbilirubinemia with G6PDd and ABO and Rh incompatibility who receive ursodeoxycholic acid at a dose of 10 mg per kilogram per day in two equal doses along with phototherapy. Intervention 2: Control group: 3 to 10-day term infants with indirect hyperbilirubinemia with G6PDd and ABO and Rh incompatibility receiving phototherapy alone. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical issues
public Dr. Sadruddin Mehdipour
Siadati St
Rasht Iran (Islamic Republic of) 4456678709 +98 13 3336 9002 Smb1355@gmail.com Rasht University of Medical Sciences scientific Dr. Sadruddin Mehdipour
Siadati St
Rasht Iran (Islamic Republic of) 4456678709 +98 13 3336 9002 Smb1355@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) parents' complete satisfaction with the presence of infants in the study infants aged 3 to 10 days birth weight: 2500 to 4000 grams exclusive breastfeeding gestational age: 37 to 41 weeks total bilirubin 14 to 20 and direct is less than 1 mg/dl 3 days 10 days Both history of any neurological disease children with a history of seizures electrolyte imbalance related to chronic disease (measured by blood test), direct hyperbilirubinemia (measured by blood test) septicemia, diseases leading to hyperbilirubinemia (Crigler-Najjar syndrome, Gilbert syndrome, hyperthyroid, hypothyroid, liver diseases) babies with jaundice without ABO and Rh incompatibility and G6PDD receiving IVIG preterm infants babies of diabetic mothers obstruction of the bile ducts babies who  have 2 or more of the mentioned risk factors at once E80 Disorders of porphyrin and bilirubin metabolism Treatment - Drugs Treatment - Drugs Intervention group: 3 to 10-day term infants with indirect hyperbilirubinemia with G6PDd and ABO and Rh incompatibility who receive ursodeoxycholic acid at a dose of 10 mg per kilogram per day in two equal doses along with phototherapy Control group: 3 to 10-day term infants with indirect hyperbilirubinemia with G6PDd and ABO and Rh incompatibility receiving phototherapy alone Bilirubin level. Timepoint: The studied infants are checked for hyperbilirubinemia upon arrival and then at least once every 12-24 hours with a serum sample. Method of measurement: BT3500 device and photometric method using 2 and 4 dichloroaniline (DCA). Duration of hospitalization. Timepoint: During the period of hospitalization of the infant, the pediatric resident visits her every 8 hours and examines her for possible complications. Method of measurement: Examination by the pediatric resident. Drug side effects. Timepoint: During the period of hospitalization of the infant, the pediatric resident visits her every 8 hours and examines her for possible complications. Method of measurement: Examination by the pediatric resident. Rasht University of Medical Sciences Approved 2023-10-18 Research Vice-Chancellor of Gilan University of Medical SciencesIR Siadati St Rasht Guilan Iran (Islamic Republic of)