Efficacy of oral phenobarbitone in term "at risk" neonates in decreasing neonatal hyperbilirubinemia: a randomized double-blinded, placebo controlled trial.

Abstract

OBJECTIVE:

To evaluate the efficacy of oral phenobarbitone in "at risk " term neonates (with high cord bilirubin) in decreasing hyperbilirubinemia.

DESIGN:

Double blind, placebo-control, randomized trial.

SETTING:

Tertiary level neonatal unit.

OUTCOME:

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.

• Authors: Ved Bhushan Arya, Ramesh Agarwal, Vinod K Paul, Ashok K Deorari
• Journal: Indian pediatrics (Indian Pediatr) Vol. 41 Issue 4 Pg. 327-32 (Apr 2004) ISSN: 0019-6061 [Print] India
• PMID: 15123861 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Excitatory Amino Acid Antagonists
• Phenobarbital

Topics

• Double-Blind Method
• Excitatory Amino Acid Antagonists (administration & dosage, therapeutic use)
• Humans
• Hyperbilirubinemia, Neonatal (prevention & control)
• Infant, Newborn
• Phenobarbital (administration & dosage, therapeutic use)
• Prospective Studies