Efficacy of oral phenobarbitone in term "at risk" neonates in decreasing neonatal hyperbilirubinemia: a randomized double-blinded, placebo controlled trial.
OBJECTIVE
To evaluate the efficacy of oral phenobarbitone in "at risk " term neonates (with high cord bilirubin) in decreasing hyperbilirubinemia.


METHODS
Double blind, placebo-control, randomized trial.


METHODS
Tertiary level neonatal unit.


RESULTS
Primary-hyperbilirubinemia defined as total serum bilirubin (TSB) greater than 13 mg/dL. Secondary-TSB at 72 +/- 12 hr, need for phototherapy or exchange transfusion and side effects of phenobarbitone therapy.


METHODS
All consecutively born term healthy neonates with cord bilirubin > or = 2.5 mg/dL were randomly assigned to receive either phenobarbitone (n = 37) or placebo (n = 38) after obtaining informed consent. Phenobarbitone was administered orally (5 mg/kg/day) for 3 days starting within 12 hours of birth. The neonates were followed up till seven days of life. TSB was estimated in neonates who developed jaundice with clinically assessed level of 8-10 mg/dL and at 72 +/-12 hours of age in 55 neonates.


RESULTS
The baseline characteristics were similar in two groups. There was no significant reduction in incidence of hyperbilirubinemia in phenobarbitone group compared to in placebo group (6/37 (16.2%) versus 13/38 (34.3%); RR 0.47, 95% confidence interval: 0.20-1.11; risk difference: -18.1%, 95% confidence interval: -39.5 to 3.3%). However TSB at 72 +/-12 hours in phenobarbitone group (mean +/- S.D: 10.0 +/- 3.7 mg/dL) was significantly lesser than in placebo group (mean +/- S.D: 12.3 +/- 3.3 mg/dL) (difference of means: -2.3 mg/dL, 95% confidence interval: -3.9 to -0.7 mg/dl, P = 0.018). No significant difference with respect to need for treatment was observed in two groups. No significant adverse effects of phenobarbitone were noted.


CONCLUSIONS
Prophylactic phenobarbitone is not helpful in reducing the incidence of hyper-bilirubinemia in "at risk" term neonates.
Arya
Ved Bhushan
VB
Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110 029, India.
Agarwal
Ramesh
R
Paul
Vinod K
VK
Deorari
Ashok K
AK
D004311:Double-Blind Method; D018691:Excitatory Amino Acid Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D051556:Hyperbilirubinemia, Neonatal / Q000517:prevention & control*; D007231:Infant, Newborn; D010634:Phenobarbital / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies
D018691:Excitatory Amino Acid Antagonists; D010634:Phenobarbital