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

Determining and comparing the effect of oral ursodeoxycholic acid along with phototherapy and phototherapy alone on indirect hyperbilirubinemia in 3- to 10-day-old term infants with G6PDd and ABO and Rh incompatibility

This research is a single-blind randomized clinical trial study with a control group of term infants with the mentioned risk factors who receive phototherapy only, randomization before starting the program using https://www.sealedenvelope.com software, taking into account 53 people in each 2 groups (Urso group, photo and phototherapy alone) will be done in blocks of 4

This research is a clinical trial study that will be conducted in 17 Shahrivar hospital in Rasht on 3-10 day term infants with risk factors

Inclusion criteria: 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. Exclusion criteria: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 w/o ABO and Rh incompatibility and G6PDD,receiving IVIG,preterm infants and babies of diabetic mothers,obstruction of the bile ducts and babies who have 2 or more risk factors at once.

3- to 10-day-old 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 and phototherapy and the control group that receives phototherapy alone

Bilirubin level؛ duration of hospitalization

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.

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.

Due to ethical issues