Melatonin possesses potential efficacy in perinatal brain injuries, and has been proposed as\nadjunctive pharmacological therapy in combination with hypothermia in the clinical setting. However,\nthe pharmacokinetics of melatonin in preterm and term newborns is still unknown. The aim of this\nstudy was to analyze the pharmacokinetics of melatonin after intragastric administration in preterm\ninfants. Preterm newborns were enrolled 24ââ?¬â??72 h after birth, and randomly assigned to three groups\nreceiving a single bolus of 0.5 mgÃ?·kgâË?â??1 melatonin, or 3 boluses of 1 or 5 mgÃ?·kgâË?â??1 of melatonin at 24-h\nintervals. Blood samples were collected before and at selective times after melatonin administration.\nThe half-life of melatonin in plasma ranged from 7.98 to 10.94 h, and the area under the curve\n(AUC) from 10.48 to 118.17 Ã?¼gÃ?·mLâË?â??1Ã?·hâË?â??1. Our results indicate a different pharmacokinetic profile\nin premature newborns, compared to adults and experimental animals. The high peak plasma\nconcentrations and the long half-life indicate that in the neonatal clinical setting, it is possible to\nobtain and maintain high serum concentrations using a single administration of melatonin repeated\nevery 12/24 h.
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