1. Clinical seizures were diagnosed by the two
residents who were trained for identifying the neonatal seizures as
per standard criteria [2].
2. We excluded babies who required ventilation
right at admission and not those who require ventilation later in
course of admission after enrolment in study. This was done to
reduce the attrition rate from the study as extramural babies coming
to us in very moribund condition had high likelihood of death
without completion of study protocol.
3. It was not at all difficult to follow this
schedule of phenobarbitone administration with the help of syringe
pump.
4. Time for peak concentration of phenobarbitone
is 0.5-4 hours. The study did not measure the peak serum levels of
phenobarbitone. Many neonates reached therapeutic level immediately
after infusion. The mean serum phenobarbitone level achieved at 20
minutes in our study was comparable to that at 12 hours. So, it can
be presumed that there will be no difference between 20 minutes and
other time intervals like 30 minutes or 2 hours as well. Some other
studies have also measured the serum phenobarbitone levels at 20
minutes [3,4].
5. As the seizure control in our study was
independent of serum levels of phenobarbitone, serum level
monitoring may not be essential in most cases who require one or two
doses of phenobarbitone. We recommend serum level monitoring in
cases where we suspect side effects of this drug, or if multiple
doses have been given (cumulative loading dose more than 30 mg/kg).
We also need to monitor drug levels in case multiple drugs are used
for seizure control as one may unpredictably increase or decrease
the drug levels of the other drug.
6. Sixty-nine percent of the seizures were
related to hypoxic ischemic encephalopathy.
