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Gemfibrozil in late preterm and term neonates with moderate jaundice: a randomized controlled trial
Jaikrishan1, Praveen Kumar, Anil Narang
1Neonatal unit, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Objective:
To determine, if oral Gemfibrozil is effective in decreasing the duration of phototherapy by at least 24 hours in neonates >34 weeks gestation with non-hemolytic jaundice, as compared to placebo.
Design:
Double blind placebo controlled randomized controlled trial.
Setting:
Tertiary care neonatal unit in north India.
Subjects:
Ninety seven neonates >34 weeks gestation with non-hemolytic jaundice within first 7 days of life requiring phototherapy.
Intervention:
Two doses of Gemfibrozil (60 mg/kg/dose) or placebo, 12 hours apart. Babies were treated with single surface special blue light phototherapy. Serum total bilirubin (STB) was measured 8 hourly. Phototherapy was stopped if two consecutive STB values were below phototherapy zone.
Primary Outcome Measure:
Duration of phototherapy.
Results:
The median (IQR) duration of phototherapy was 40 (30, 60) hours in Gemfibrozil and 36 (19, 55) hours in the placebo group (P=0.13). The peak STB levels were 16.8 +/- 2.7 mg/dL and 16.3 +/- 2.3 mg/dL in Gemfibrozil and placebo groups, respectively. No side effect of the drug or placebo was noticed.
Conclusion:
Two doses of gemfibrozil (60 mg/kg/dose) given 12 hours apart were not able to reduce the duration of phototherapy, or peak bilirubin level in babies > 34 weeks gestation with non-hemolytic jaundice in the first week of life. Gemfibrozil was not associated with any side effects.
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