BACKGROUND: Hyperbilirubinemia is a common neonatal problem. The present study aimed to investigate the effect of ursodeoxycholic acid in reducing indirect hyperbilirubinemia of infants under phototherapy. METHODS: This double-blind randomized clinical trial was conducted on neonates with jaundice, who had received phototherapy in the hospitals affiliated with the Shiraz University of Medical Sciences in 2013. A total of 80 neonates were enrolled in the study and were randomly divided into 2 groups. The intervention group (n = 0) with indirect hyperbilirubinemia received 10 mg · kg(-1) · day(-1) divided every 12 hours Ursobil (capsule 300 mg) in addition to phototherapy, whereas the control group (n = 0) received only phototherapy. Total bilirubin levels were measured every 12 hours until reaching <10 mg/dL, and then phototherapy was disrupted. The duration of phototherapy was measured. The 2 groups were compared regarding total bilirubin levels at different time points and duration of phototherapy using the generalized estimating equation (GEE) test. RESULTS: The mean of total bilirubin in the intervention group was 12 ± 1.6, 10 ± 1.1, and 9.8 ± 0.2 mg/dL 12, 24, and 48 hours after the beginning of phototherapy, respectively. On the contrary, these measures were 14.4 ± 1.3, 12.5 ± 1.4, and 10.1 ± 1.1 mg/dL in the control group, respectively, (P < 0.05). The mean time required for phototherapy to decrease the bilirubin level to < 10 mg/dL was 15.5 ± 6 and 44.6 ± 13.3 hours in the case and the control group, respectively, (P = 0.001). CONCLUSIONS:Ursodeoxycholic acid had additive effect with phototherapy in neonates with indirect hyperbilirubinemia. This drug also reduced the time period needed for phototherapy and, consequently, decreased the hospitalization period.
RCT Entities:
BACKGROUND:Hyperbilirubinemia is a common neonatal problem. The present study aimed to investigate the effect of ursodeoxycholic acid in reducing indirect hyperbilirubinemia of infants under phototherapy. METHODS: This double-blind randomized clinical trial was conducted on neonates with jaundice, who had received phototherapy in the hospitals affiliated with the Shiraz University of Medical Sciences in 2013. A total of 80 neonates were enrolled in the study and were randomly divided into 2 groups. The intervention group (n = 0) with indirect hyperbilirubinemia received 10 mg · kg(-1) · day(-1) divided every 12 hours Ursobil (capsule 300 mg) in addition to phototherapy, whereas the control group (n = 0) received only phototherapy. Total bilirubin levels were measured every 12 hours until reaching <10 mg/dL, and then phototherapy was disrupted. The duration of phototherapy was measured. The 2 groups were compared regarding total bilirubin levels at different time points and duration of phototherapy using the generalized estimating equation (GEE) test. RESULTS: The mean of total bilirubin in the intervention group was 12 ± 1.6, 10 ± 1.1, and 9.8 ± 0.2 mg/dL 12, 24, and 48 hours after the beginning of phototherapy, respectively. On the contrary, these measures were 14.4 ± 1.3, 12.5 ± 1.4, and 10.1 ± 1.1 mg/dL in the control group, respectively, (P < 0.05). The mean time required for phototherapy to decrease the bilirubin level to < 10 mg/dL was 15.5 ± 6 and 44.6 ± 13.3 hours in the case and the control group, respectively, (P = 0.001). CONCLUSIONS:Ursodeoxycholic acid had additive effect with phototherapy in neonates with indirect hyperbilirubinemia. This drug also reduced the time period needed for phototherapy and, consequently, decreased the hospitalization period.
Authors: Lori W E van der Schoor; Henkjan J Verkade; Anna Bertolini; Sanne de Wit; Elvira Mennillo; Eva Rettenmeier; André A Weber; Rick Havinga; Petra Valášková; Jana Jašprová; Dicky Struik; Vincent W Bloks; Shujuan Chen; Andrea B Schreuder; Libor Vítek; Robert H Tukey; Johan W Jonker Journal: Sci Rep Date: 2021-05-27 Impact factor: 4.379