Effects of Two Different Doses of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates with Glucose-6-phosphate Dehydrogenase Deficiency Treated with Phototherapy: A Randomized Controlled Trial

Author:

Farhadi Roya1ORCID,Keyhanian Elham1,Naderisorki Mohammad2,Nadi Ghara Aliasghar3

Affiliation:

1. Pediatric Infectious Diseases Research Center, Mazandaran University of Medical Sciences, Sari, Iran

2. Thalassemia Research Center, Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran

3. Health Science Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran

Abstract

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is one of the causes of severe hyperbilirubinemia, prolonged jaundice, and bilirubin-induced encephalopathy in neonates. In a randomized controlled trial, we evaluated the effect of oral ursodeoxycholic acid (UDCA) on indirect hyperbilirubinemia in G6PD-deficient neonates requiring phototherapy. Intervention group I (N = 45; received phototherapy and 10 mg/kg/day UDCA), Intervention group II (N = 40; received phototherapy and 20 mg/kg/day UDCA), and a control group (N = 49; received phototherapy and placebo). Levels of total serum bilirubin (TSB) in all 3 groups decreased significantly over time ( P = .001) but the level of TSB at different hours after admission and the duration of phototherapy did not differ significantly between the 3 groups. After discharge, the 2 intervention groups had a significantly lower rate of readmission than the control group ( P = .001). No significant difference was observed between the 10 and 20 mg/kg/day groups. Further evaluation is recommended, especially in terms of the pharmacokinetics of UDCA in neonates. Trial registration number: IRCT20091201002801N4, prospectively registered on 2019-06-1

Funder

Mazandaran University of Medical Sciences

Publisher

SAGE Publications

Subject

Pediatrics,Pediatrics, Perinatology and Child Health

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