Abstract
Objective
Phenobarbital crosses the placenta quickly, and the balance between maternal and fetal
blood is achieved in a few minutes. Data on the clinical outcomes of infants born
to mothers under phenobarbital treatment during pregnancy show that they are at risk
of adverse events, such as sedation and abstinence syndrome. The aim of this study
was to analyse the correlation between serum levels of phenobarbital and clinical
features of neonates.
Study design
Twenty-three infants born between 2001 and 2008 were studied. Maternal, neonatal and
pharmacological variables were considered.
Results
Eleven infants displayed symptoms related to phenobarbital. Withdrawal syndrome was
seen in seven infants and sedation syndrome was seen in four infants. One infant had
severe cardiorespiratory depression at birth. None of the infants had severe neonatal
abstinence syndrome. No statistically significant differences were found between symptomatic
and asymptomatic infants. At birth, the mean serum level of phenobarbital of the 23
infants was 15.4 [standard deviation (SD) 6.2] μg/ml. A peak (16.1 μg/ml, SD 5.5) was seen on Day 3, followed by a gradual decrease to non-therapeutic
levels (<10 μg/ml) by Day 8 (9.3 μg/ml, SD 1.0). Phenobarbital levels were higher in symptomatic infants than asymptomatic
infants, although the difference was not statistically significant.
Conclusions
Serum levels of phenobarbital remained in the therapeutic range for both mothers and
infants, and reduced gradually in infants. However, some infants displayed symptoms
related to phenobarbital. As such, a clinical pharmacological surveillance protocol
is necessary.
Keywords
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Article info
Publication history
Published online: June 27, 2011
Accepted:
June 9,
2011
Received in revised form:
May 4,
2011
Received:
September 12,
2010
Identification
Copyright
© 2011 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.
