Efficacy of oral phenobarbitone in term "at risk" neonates in decreasing neonatal hyperbilirubinemia: a randomized double-blinded, placebo controlled trial.
Indian Pediatr
;
2004 Apr; 41(4): 327-32
Article
in English
| IMSEAR
| ID: sea-7034
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.
Full text:
Available
Index:
IMSEAR (South-East Asia)
Main subject:
Phenobarbital
/
Humans
/
Infant, Newborn
/
Double-Blind Method
/
Prospective Studies
/
Excitatory Amino Acid Antagonists
/
Hyperbilirubinemia, Neonatal
Type of study:
Controlled clinical trial
/
Etiology study
/
Observational study
Language:
English
Journal:
Indian Pediatr
Year:
2004
Type:
Article
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