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[Preventive treatment of convulsions in perinatal asphyxia]
Insights
Phenobarbital and phenytoin were studied in newborns with perinatal asphyxia to prevent seizures. Phenobarbital showed increasing blood levels and side effects, while phenytoin had limited efficacy, indicating challenges in seizure prevention for this condition.
Area of Science:
- Neonatal neurology
- Pharmacology
Background:
- Perinatal asphyxia is a significant cause of neonatal seizures.
- Effective anticonvulsant therapy is crucial for managing seizures in newborns.
- Phenobarbital and phenytoin are commonly considered for neonatal seizure management.
Purpose of the Study:
- To compare the efficacy and safety of phenobarbital and phenytoin in preventing seizures in newborns with perinatal asphyxia.
- To monitor drug blood levels and clinical outcomes in treated infants.
Main Methods:
- A double-blind, randomized study involving 17 newborn infants.
- Infants received either phenobarbital (FB) or phenytoin (DPH) at a dose of 12 mg/kg on day 1, followed by 6 mg/kg/day for seven days.
- Daily clinical assessments and daily drug blood level determination using enzyme immunoassay (EMIT).
Main Results:
- Phenobarbital (FB) blood levels progressively increased over seven days, reaching a mean of 44.6 µg/ml. Six infants on FB experienced drowsiness and bradycardia, attributed to high FB levels.
- Phenytoin (DPH) levels fluctuated, with a maximum mean of 9.7 µg/ml. One DPH-treated infant had seizures, and four showed signs of therapeutic inefficacy (hypertonus, abnormal movements).
Conclusions:
- Both phenobarbital and phenytoin present challenges in achieving effective seizure prevention and maintaining safe therapeutic levels in newborns with perinatal asphyxia.
- High phenobarbital levels were associated with adverse effects, while phenytoin demonstrated limited efficacy in this cohort.
Abstract:
A double blind randomized study has been performed in 17 newborn infants bearing a diagnosis of perinatal asphyxia and treated with phenobarbital (FB) or phenytoin (DPH) to prevent the onset of seizures. The initial dose for both drugs was 12 m/kg IM the first day, followed by 6 mg/kg/day through the seventh day. Patients were clinically assessed daily and drug blood levels were also determined daily by enzyme immunoassay (EMIT). Mean FB levels along the seven days were 17.6, 23.7, 25.6, 31.6, 31.4, 36.7, and 44.6 micrograms/ml. One child treated with FB exhibited seizures on the second day and six children showed drowsiness and bradycardia on the last two days, that were attributable to high levels of FB. Mean (DPH) levels along the study were: 4.6, 7.0, 9.7, 6.5, 4.5, and 5.2 micrograms/ml. Seizures occurred in one of the DPH-treated patients and signs of therapeutic inefficacy such as hypertonus and abnormal movements appeared in four children.