Gemfibrozil in late preterm and term neonates with moderate jaundice: a randomized controlled trial.
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.


METHODS
Double blind placebo controlled randomized controlled trial.


METHODS
Tertiary care neonatal unit in north India.


METHODS
Ninety seven neonates >34 weeks gestation with non-hemolytic jaundice within first 7 days of life requiring phototherapy.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Jaikrishan
Neonatal unit, Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Kumar
Praveen
P
Narang
Anil
A
D001663:Bilirubin / Q000097:blood; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D015248:Gemfibrozil / Q000009:adverse effects / Q000627:therapeutic use*; D005955:Glucosephosphate Dehydrogenase Deficiency; D006801:Humans; D007231:Infant, Newborn; D007567:Jaundice, Neonatal / Q000188:drug therapy*; D016015:Logistic Models; D010789:Phototherapy; D016896:Treatment Outcome
D015248:Gemfibrozil; D001663:Bilirubin