2004, Number 2
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Gac Med Mex 2004; 140 (2)
Prevention of Hypoxic-Ischemic Encephalopathy with High-Dose, Early Phenobarbital Therapy.
Vargas-Origel A, Espinosa-García JOG, Muñiz-Quezada E, Vargas-Nieto MA, Aguilar-García G
Language: Spanish
References: 21
Page: 147-154
PDF size: 469.33 Kb.
ABSTRACT
Objective: to assess usefulness of high-dose early phenobarbital
therapy for prevention of hypoxic-ischemic encephalopathy
(HIE) secondary to perinatal asphyxia (PNA).
Material and Methods: by means of a randomized clinical
trial, asphyxiated full-term or post-term newborn infants were
divided in two groups: Group A was the experimental group,
while group B was the control group. Infants in group A
received phenobarbital, 40 mg/kg, during the first 60 min after
birth. Infants on group B received phenobarbital at
conventional doses, only if there was clinical evidence of
seizures; otherwise, treatment was similar in both groups. We
estimated frequency of HIE according to Sarnat classification
and also rate of post-asphyxial complications in other organs.
Phenobarbital levels were measured in Group A. Statistical
tests used were Student t, Mann-Whitney U, Χ2, or Fisher.
Informed consent was obtained from parents of each infant.
Results: 37 infants belonged to Group A, while Group B was
composed of 36 infants. Both groups were similar in sex,
gestational age and cord gases. Birth weight was higher in Group
A (p<0.05). Diagnostic criteria for PNA a cord pH ≤ 7.00 plus
one or two criteria of commonly used parameters for asphyxia.
There was a difference in total dose of phenobarbital and time of
initial dose in both groups. HIE was present in 13.5% (5/37) of
group A, and 22.2% (8/36) of group B. Seizures (Stage II of HIE)
occurred in 10.8% (4/37) and 11.1% (4/36), respectively, without
significant statistical difference. There was also no difference in
rate of post-asphyxial, non-brain complications in both groups.
There were no side effects or changes in vital signs associated with
use of phenobarbital. Only one infant had toxic phenobarbital
serum levels.
Discussion: there was no significant difference in the overall
frequency of HIE, nor in the incidence of seizures or stage II
of HIE in both groups. According to these results and even
though there were no side effects, we think Phenobarbital is
not useful for these purposes. Long-term follow-up of the
treated infants is justified, since Phenobarbital might have a
beneficial effect on neuro-behavioral development.
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