Strong Variability of Di(2-ethylhexyl)phthalate (DEHP) Plasmatic Rate in Infants and Children Undergoing 12-Hour Cyclic Parenteral Nutrition.

Abstract

BACKGROUND: Medical devices such as perfusion materials in polyvinyl chloride may contain di(2-ethylhexyl)phthalate (DEHP). Several studies have questioned the harmlessness of phthalates, which have been shown to have toxic effects on the reproductive system and general development. This study was designed to assess DEHP exposure in infants and children benefitting from cyclic parenteral nutrition (PN). The results are compared with those obtained from children used as controls and receiving no PN, to estimate the potential risk to this pediatric population, taking into account exposure levels and already published data. METHODS: Plasmatic concentrations of DEHP were assessed by high-performance liquid chromatography from blood samples taken from 22 children at the start and finish of a 12-hour cyclic PN period and compared with those obtained from 20 control children of comparable age and gender. RESULTS: After a 12-hour cyclic PN period, DEHP migration varied widely among the patients. The concentrations were not quantifiable in 4 children at the start of PN. In 1 child, they were quantifiable neither at the start nor at the end of PN. However, for 17 children, DEHP concentrations were quantifiable at the start of PN and were very variable from one child to another. At the end, DEHP concentrations had significantly but variably increased in these children. No trace of DEHP was found in the blood samples from 20 healthy controls. Conclusion: Considering published data on phthalate toxicity, it would appear advisable to encourage the use of medical devices that are either phthalate or DEHP free. (JPEN J Parenter Enteral Nutr. XXXX;xx:xx-xx).