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J Matern Fetal Neonatal Med. 2005 Dec;18(6):391-5.

A randomized controlled trial of phenobarbital in neonates with hypoxic ischemic encephalopathy.

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  • 1Neonatal Unit, Department of Pediatrics, Advanced Pediatrics Centre, PGIMER, Chandigarh, India.

Abstract

BACKGROUND:

Phenobarbital is one of the oldest, cheapest and most easily available cerebro-protective drugs for the hypoxic brain. It has multiple actions that could be of benefit to the asphyxiated brain. However, its potential has not been fully explored.

OBJECTIVE:

To study the effect of phenobarbital given within six hours of life to term and near-term asphyxiated neonates, on mortality, neurological abnormality at discharge and seizures.

METHODS:

This was a randomized controlled trial set in a tertiary care referral perinatal centre. Asphyxiated neonates (gestational age >or= 34 weeks) manifesting with hypoxic ischemic encephalopathy (HIE) in the first six hours of life were randomized to receive either injection of phenobarbital 20 mg/kg IV or to the control group. The primary outcome was death or abnormal neurological examination at discharge while seizures, need for ventilation and multi-organ dysfunction were secondary outcomes.

RESULTS:

Twenty-five babies received phenobarbital and 20 were in the control group. The mortality (20% vs. 15%) and abnormal neurological outcome at discharge (30% vs. 53%, p = 0.15) were statistically not different between the two groups. In the phenobarbital group, 8% of neonates developed seizures while 40% of babies in the control group developed seizures (p = 0.01, relative risk (RR) = 0.20 (0.05-0.84)). Phenobarbital was well tolerated and did not increase the need for respiratory support.

CONCLUSIONS:

Phenobarbital in the dose of 20 mg/kg IV given within six hours of life to term and near-term neonates with HIE, significantly decreased the incidence of neonatal seizures and was well tolerated. However, it did not alter the mortality and neurologic outcome at discharge.

[PubMed - indexed for MEDLINE]
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