BACKGROUND: Despite an understanding of the enzymatic pathways leading to bilirubin production and degradation, very few pharmacologic interventions are utilized and the mainstay of treatment remains phototherapy. AIMS: To evaluate the efficacy of clofibrate in reducing total serum bilirubin levels in late pre-term neonates with non-hemolytic jaundice. DESIGN AND SETTING: Double-blind, placebo-controlled, randomized trial; tertiary level neonatal unit. MATERIALS AND METHODS: A randomized controlled study was carried out in the neonatal ward of Children's Hospital, Tabriz, Iran, over a 1-year period. Sixty-eight healthy late pre-term infants readmitted with non-hemolytic hyperbilirubinemia were randomized to receive phototherapy and clofibrate (n= 35) or phototherapy and placebo (n= 33). STATISTICAL ANALYSIS USED: Chi-square test and independent sample 't' test. RESULTS: There were no significant differences in the weight, gender, modes of delivery and age of neonates between the two groups. Similarly the mean total serum bilirubin (TSB) level at the time of admission was not significantly different between the two groups [mean+/- SD: 19.72 +/- 1.79 (95% confidence interval: 19.12-20.54 mg/dL) vs. 20.05 +/- 2.82 (95% confidence interval, 19.54-22.04 mg/dL), P= 0.57]. The mean TSB 48 hours after phototherapy [mean+/- SD: 8.06+/- 1.34 (95% confidence interval: 7.94-10.18 mg/dL) vs.10.94 +/- 2.87 (95% confidence interval: 9.92-12.16 mg/dL), P= 0.02] and the mean duration of phototherapy [mean+/- SD: 64.32 +/- 12.48 (95% confidence interval: 60-81.6 hours) vs. 87.84 +/- 29.76 (95% confidence interval: 79.2-108 hours), P< 0.001] were significantly lower in the clofibrate-treated group. CONCLUSIONS: Clofibrate is an effective adjunctive drug in neonatal hyperbilirubinemia, which results in decreased TSB level and reduced duration of phototherapy in late pre-term newborns.
BACKGROUND: Despite an understanding of the enzymatic pathways leading to bilirubin production and degradation, very few pharmacologic interventions are utilized and the mainstay of treatment remains phototherapy. AIMS: To evaluate the efficacy of clofibrate in reducing total serum bilirubin levels in late pre-term neonates with non-hemolytic jaundice. DESIGN AND SETTING: Double-blind, placebo-controlled, randomized trial; tertiary level neonatal unit. MATERIALS AND METHODS: A randomized controlled study was carried out in the neonatal ward of Children's Hospital, Tabriz, Iran, over a 1-year period. Sixty-eight healthy late pre-term infants readmitted with non-hemolytic hyperbilirubinemia were randomized to receive phototherapy and clofibrate (n= 35) or phototherapy and placebo (n= 33). STATISTICAL ANALYSIS USED: Chi-square test and independent sample 't' test. RESULTS: There were no significant differences in the weight, gender, modes of delivery and age of neonates between the two groups. Similarly the mean total serum bilirubin (TSB) level at the time of admission was not significantly different between the two groups [mean+/- SD: 19.72 +/- 1.79 (95% confidence interval: 19.12-20.54 mg/dL) vs. 20.05 +/- 2.82 (95% confidence interval, 19.54-22.04 mg/dL), P= 0.57]. The mean TSB 48 hours after phototherapy [mean+/- SD: 8.06+/- 1.34 (95% confidence interval: 7.94-10.18 mg/dL) vs.10.94 +/- 2.87 (95% confidence interval: 9.92-12.16 mg/dL), P= 0.02] and the mean duration of phototherapy [mean+/- SD: 64.32 +/- 12.48 (95% confidence interval: 60-81.6 hours) vs. 87.84 +/- 29.76 (95% confidence interval: 79.2-108 hours), P< 0.001] were significantly lower in the clofibrate-treated group. CONCLUSIONS: Clofibrate is an effective adjunctive drug in neonatal hyperbilirubinemia, which results in decreased TSB level and reduced duration of phototherapy in late pre-term newborns.