The pharmacokinetic profile of caffeine was studied in 15 premature infants.
Five infants received a single intravenous dose of 10 mg/kg of caffeine citrate 100% at birth
and on the 15th day of life. Ten neonates were studied during daily therapy with caffeine for
prophylaxis of idiopathic apnea. The time course of plasma and urinary concentrations of
caffeine and theophylline shows that caffeine is transformed to theophylline at birth, while
total urinary xanthines decrease significantly (p < 0.001) 72 h after the loading dose given
on the 15th day of life. During the whole period of treatment, the decrease in total urinary
xanthines and the constant urinary percentage elimination of theophylline are due to further
metabolism of theophylline. We confirm that the intravenous loading dose of 10 mg/kg can
rapidly obtain therapeutic blood levels of caffeine. We also confirm that the maintenance
therapy can be carried out with a single daily dose.
The placental transfer of phénobarbital was investigated in 35
mother-infant pairs at birth. The drug was administered prenatally
to the mothers for maternal epilepsy (group 1, n = 5),
gestational hypertension and preeclampsia (group 2, n = 20)
and prophylaxis of intraventricular hemorrhage in premature
deliveries (group 3, n = 10). The phénobarbital levels in
arterial cord blood were 100 ± 2.8% in group 1, 89 ± 21% in
group 2 and 77 ± 16% in group 3 with respect to the levels
observed in the mothers. The most important factor influencing
the transplacental passage was the duration of maternal
treatment in the infant of group 1 (r = 0.80, p < 0.01), the
gestational age in the infants of group 2 (r = 0.74, p < 0.01)
and the arterial cord pH in the infants of group 3 (r = 0.89, p <
0.001).
In a randomized prospective study, we investigated the effect of antenatal phenobarbital on neonatal intraventricular hemorrhage in 39 women destined to deliver babies of less than 32 weeks of gestation. The treatment group received an intravenous loading dose of 700 mg of phenobarbital, followed by a daily maintenance dose until delivery. The newborns were treated with phenobarbital for the first 96 h. Ultrasound examinations of the infants’ heads were performed. Intraventricular hemorrhage was significantly less frequent in the treated group: 2 of 21 (9.5%) versus 9 of 18 (50%; p < 0.006). Moreover no severe hemorrhage (grade 3–4) occurred in the treated babies: 0 of 21 versus 5 of 18 (27.7%; p < 0.01).
The serum concentration of phenobarbital used as an anticonvulsant was monitored
in 30 preterm babies. The therapeutic serum concentration was achieved with a loading
dose of 20 mg/kg i.v., 10 min after administration. Thirty-six hours after loading, it was
possible to maintain therapeutic serum levels with a daily intramuscular dose of 5 mg/kg,
avoiding toxicity. A comparison of CSF and serum concentrations indicated that the drug
passage to CSF is rapid and depends on a brain lesion. Serum monitoring of phenobarbital is
important in preterm neonates under 30 weeks gestation and/or with severe pathological
complications.
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