Manizheh Mostafa GHAREHBAGHI, Afsaneh Mokhallegh SANI, Mandana REFEEY

Evaluating the effects of different doses of ursodeoxycholic acid on neonatal jaundice

Background. Icterus tends to be one of the most prevalent causes of neonatal hospitalization. The present study aimed to evaluate the effects of the different doses of ursodeoxycholic acid (UDCA) on neonatal jaundice. Method. In this study, 120 newborns who were hospitalized for phototherapy were randomly assigned. Group A received phototherapy and UDCA 5 mg/kg/dose every 12 hours orally, group B patients were treated with phototherapy and UDCA 7.5 mg/kg/dose every 12 hours orally. Group C received phototherapy with a placebo. All patients were evaluated for bilirubin levels, the duration of phototherapy, and the length of hospital stay.Results. The mean bilirubin level at hospital admission was 19.88 ± 2.33 mg/dl in group A, 19.33 ± 2.51 mg/dl in group B, and 19.76 ± 2.64 mg/dl in group C (p= 0.58). The groups receiving phototherapy with UDCA showed a significant decrease in the bilirubin level. Bilirubin level decreased to 10.04 ± 1.11mg/dl in group A, 8.82 ± 1.11 mg/dl in group B, and 12.04 ± 2.05 mg/dl in group C (p= 0.000). Furthermore, the mean duration of phototherapy, as well as the average length of hospital stay, were significantly lower in group B as compared to the other groups (p= 0.000).Conclusion. The findings of this study indicated that the administration of UDCA in addition to phototherapy could effectively decrease the length of hospital stay and bilirubin levels in neonatal hyperbilirubinemia. However, further studies with a larger sample size are required before one can recommend the routine use of UDCA for the treatment of neonatal jaundice.

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1. Stevenson DK, Fanaroff AA, Maisels MJ, et al. Prediction of hyperbilirubinemia in near-term and term infants. Pediatrics 2001; 108: 31-39.

2. Faulhaber FRS, Procianoy RS, Silveira RC. Side effects of phototherapy on neonates. Am J Perinatol 2019; 36: 252-257.

3. American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics 2004; 114: 297- 316.

4. Ip S, Chung M, Kulig J, et al; American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. An evidence-based review of important issues concerning neonatal hyperbilirubinemia. Pediatrics 2004; 114: e130-e153.

5. Moslehi MA, Pishva N. Determination of the effect of low dose vs moderate dose clofibrate on decreasing serum bilirubin in healthy term neonates. Iran J Ped 2007; 17: 108-112.

6. Pashapour N, Maccoei A, IOU SG, Akhondi H. The study of a new method in treatment of term newborns with non-hemolytic hyperbilirubinemia. Med J Islamic World Acad Sci 2010; 18: 5-8.

7. Zahedpasha Y, Ahmadpour-Kacho M, Hajiahmadi M, Naderi S. Effect of clofibrate in jaundiced fullterm infants: a randomized clinical trial. Arch Iran Med 2007; 10: 349-353.

8. Dennery PA. Pharmacological interventions for the treatment of neonatal jaundice. Semin Neonatol 2002; 7: 111-119.

9. Cuperus FJ, Hafkamp AM, Havinga R, et al. Effective treatment of unconjugated hyperbilirubinemia with oral bile salts in Gunn rats. Gastroenterology 2009: 136: 673-682.e1.

10. Gludd C, Christensen E. Ursodeoxycholic acid for primary biliary cirrhosis. Cochrane Database Syst Rev 2002; 1: CD00051.

11. Honar N, Ghashghaei Saadi E, Saki F, Pishva N, Shakibazad N, Hosseini Teshnizi S. Effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonates treated with phototherapy. J Pediatr Gastroenterol Nutr 2016; 62: 97-100.

12. Sokol RJ, Durie PR. Recommendation for management of liver and biliary tract disease in cystic fibrosis. Cystic fibrosis foundation hepatobiliary disease consensus group. J Pediatr Gastroenterol Nutr 1999; 28(Suppl 1): s1-s13.

13. Beuers F, Lindor KD. A major step towards effective treatment evaluation in primary biliary cirrhosis. J Hepatol 2011; 55: 1178-1180.

14. Mendes F, Lindor KD. Primary sclerosing cholangitis: overview and update. Nat Rev Gastroenterol Hepatol 2010; 7: 611-619.

15. Balistreri WF. Bile acid therapy in pediatric hepatobiliary disease: the role of ursodeoxycholic acid. J Pediatr Gastroenterol Nutr 1997; 24: 573-589.

16. Hassan MA, Abdulrahman A, Hasan Husain R. Effect of ursodeoxycholic acid in lowering neonatal indirect hyperbilirubinemia: a randomized controlled trial. Merit Res J Med Med Sci 2015; 3: 402-405.

17. Jafari SH, Khan KA, Bhatnagar SH, Srivastava G, Nanda C, Chandra A. Role of ursodeoxycholic acid in neonates with indirect hyperbilirubinemia-an open labeled randomized control trial. Int J Contemp Pediatr 2018; 5: 432-435.

18. George R, Stevens A, Berkenbosch JW, Turpin J, Tobias J. Ursodeoxycholic acid in the treatment of cholestasis and hyperbilirubinemia in pediatric intensive care unit patients. South Med J 2002; 95: 1276-1279.

19. Maldonado SR, Godínez Téllez NC, Yescas-Buendía G, Fernán-Carrocera LA, Echaniz- Avilés OL, Reyna Ríos ER. Effectiveness of ursodeoxycholic acid vs. phenobarbital for the treatment of neonatal cholestasis: a cross-randomized clinical trial. Bol Med Hosp Infant Mex 2010; 67: 418-424.

20. Rina RM, Oswari H, Amalia P. Ursodeoxycholic acid in neonatal sepsis-associated cholestasis. Paediatr Indones 2014; 54: 206-212.

21. Bowlus CL, Kenney JT, Rice G, Navarro R. Primary biliary cholangitis: medical and specialty pharmacy management update. J Manag Care Spec Pharm 2016; 22(10-a-s Suppl): S3-S15.

22. Lewis T, Kuye S, Sherman A. Ursodeoxycholic acid versus phenobarbital for cholestasis in the Neonatal Intensive Care Unit. BMC Pediatr 2018; 18: 197.