Therapeutic effect of oral ursodeoxycholic acid on indirect hyperbilirubinemia in full-term neonates undergoing phototherapy in hospital 17 Shahrivar - a randomized controlled clinical trial

Comparison of oral Urso with phototherapy and phototherapy alone in indirect hyperbilirubinemia reduction in term neonates undergoing phototherapy in hospital 17 Shahrivar

A clinical trial with the control group, without blinding, randomized, phase 3, on 106 patients. sealedenvelope software is used for randomization.

This study is a randomized clinical trial that will be performed on 3 to 7-day old neonates who are admitted due to jaundice after receiving the code of ethics for 8 months in 17 Shahrivar Hospital in Rasht. After selecting the infants according to the inclusion and exclusion criteria, written consent will be obtained from the parents and in the next step. Patients will be divided into 2 groups. Group A will receive oral Urso with phototherapy and group B will receive phototherapy alone (control). The drug is evaluated and visited by a Pediatric resident, and in case of complications, the drug will be discontinued. 1- Urso is administered orally at a dose of 10 mg/kg in divided doses every 12 hours and at the time of hospitalization. This dose will be dissolved in breast milk.

Inclusion criteria include the complete satisfaction of parents with the presence of children in the study, birth weight: 2500 to 4000 grams, exclusive breastfeeding, gestational age 38 to 41 weeks, age 3 to 7 days, total bilirubin 14 to 20 and less direct Of 2. Criteria for non-entry include ABO and RH incompatibility, G6PDd, direct hyperbilirubinemia, septicemia

Urso at a dose of 10 mg/kg daily in infants receiving phototherapy during hospitalization

The primary outcome is bilirubin levels, which will be recorded within three to four days of hospitalization. The secondary outcome is the length of hospital stay - drug side effects and the timing of bilirubin testing.

Randomization before the start of the program will be done by the software https://www.sealedenvelope.com with 53 people in each of the 2 groups (Urso and Photo and Control groups) in blocks of 4 and each of them inside A separate envelope is placed according to the list obtained from the software and is closed in it and will be given to the third person. If the patient visits and is eligible, the envelope is opened and treated according to the desired sequence without knowing the next treatment. . It should be noted that according to the grouping performed, patients will be divided into 2 groups based on random assignment done with the software. It is the responsibility of the pediatric resident to evaluate other variables and variables related to hyperbilirubinemia and to evaluate the side effects of the drug on a daily basis during hospitalization. Group A will receive oral Urso with phototherapy and group B will receive phototherapy alone (control). • 1, 4, 1, Group B • 1, 4, 2, Group B • 1, 4, 3, Group A • 1, 4, 4, Group A • 2, 4, 1, Group B

Regarding the ethical issues and confidentiality