Clofibrate in the Treatment of the Non-hemolytic Hyperbilirubinemia in Preterm Neonates in Western Iran

Document Type : Original Article


1 Hamadan University of Medical Sciences, Hamadan, Iran

2 Autism Spectrum Disorders Research Center, Hamadan University of Medical Sciences, Hamadan, Iran

3 Department of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran


Background: No studies, to the best of our knowledge, have been conducted on the effect of Clofibrate in reducing hyperbilirubinemia in preterm infants. Therefore, this study aimed at investigating the therapeutic effect of Clofibrate in treating hyperbilirubinemia of preterm neonates.
Methods: This clinical trial was performed from April 4 to December 20, 2019, on neonates in Hamadan in western Iran. The allocation remained concealed to the researcher, neonates’ parents, and analyzer during the study. A dose of Clofibrate of 25 kg/mg was given on the first day of hospitalization. The neonates in the placebo group received the oral placebo 25 kg/mg in the same way as the oral Clofibrate. The data were analyzed using SPSS 16 with P-value < 0.05.
Results: No statistically significant difference was observed in the baseline characteristics of the two groups based on the neonate’s age and gender, delivery method, and gestational age. The prescription of Clofibrate significantly reduced the duration of hospitalization (p= 0.002) and phototherapy (p= 0.001). Prescribing a single oral dose of Clofibrate (25 mg/Kg) along with phototherapy in preterm neonates significantly reduced total serum bilirubin levels at 24 and 48 hours after treatment compared with phototherapy alone (p= 0.001). However, this association was not significant in admission (p= 0.095).
Conclusion: The findings of this study showed the effect of Clofibrate in treating hyperbilirubinemia of preterm neonates. In addition, prescribing Clofibrate significantly reduced the duration of hospitalization and phototherapy.


  1. Torabi Z, Eskandarzadeh A, Ahmadiafshar A. The effect of clofibrate with phototherapy on full-term newborns with non-hemolytic jaundice. Iran Red Crescent Med J. 2013; 15(4):285-6.
  2. Bhutani VK, Zipursky A, Blencowe H, Khanna R, Sgro M, Ebbesen F, et al. Neonatal hyperbilirubinemia and Rhesus disease of the newborn: incidence and impairment estimates for 2010 at regional and global levels. Pediatr Res. 2013; 74(S1):86-100.
  3. Méndez-Sánchez N, Vítek L, Aguilar-Olivos NE, Uribe M. Bilirubin as 13. Biomarkers in Liver Disease. Berlin, Germany: Springer; 2017. P. 281.
  4. Shapiro SM, Riordan SM. Review of bilirubin neurotoxicity II: preventing and treating acute bilirubin encephalopathy and kernicterus spectrum disorders. Pediatr Res. 2020; 87(2):332-7.
  5. Gholitabar M, McGuire H, Rennie J, Manning D, Lai R. Clofibrate in combination with phototherapy
    for unconjugated neonatal hyperbilirubinaemia. Cochrane Database Syst Rev. 2012; 12(12):
  6. Hamidi M, Zamanzad B, Mesripour A. Comparing the effect of clofibrate and phenobarbital on the newborns with hyperbilirubinemia. Excli J. 2013; 12:75-8.
  7. Eghbalian F, Pourhossein A, Zandevakili H. Effect of clofibrate in non-hemolytic indirect hyperbili-rubinemia in full term neonates. Indian J Pediatr. 2007; 74(11):1003-6.
  8. Kumar P, Adhisivam B, Bhat BV. Clofibrate as an adjunct to phototherapy for unconjugated hyperbilirubinemia in term neonates. Indian J Pediatr. 2017; 84(10):763-7.
  9. Fallah R, Islami Z, Lotfi SR. Single dose of 50 mg/kg clofibrate in jaundice of healthy term neonates: randomised clinical trial of efficacy and safety. Indian J Pediatr. 2012; 79(2):194-7.

10. Eghbalian F, Monsef F, Alam Ghomi N, Monsef A. Effect of low versus moderate dose of clofibrate on serum bilirubin in healthy term neonates with indirect hyperbilirubinemia. Iran J Med Sci. 2013; 38(4):349-50.

11. Zahed Pasha Y, Alizadeh-Tabari S, Zahed Pasha E, Zamani M. Etiology and therapeutic management of neonatal jaundice in Iran: a systematic review and meta-analysis. World J Pediatr. 2020; 16(5):480-93.

12. Lindenbaum A, Delaporte B, Benattar C, Dehan M, Magny JF, Gerbet D, et al. Preventive treatment of jaundice in premature newborn infants with clofibrate. Double-blind controlled therapeutic trial. Arch Fr Pediatr. 1985; 42(9):759-63.