473 Prospective Evaluation of Propylene Glycol Tolerance in (PRE) Term Neonates: An Active Comparator Approach

Abstract

Introduction: Propylene glycol (PG) is a commonly used excipiens although accumulation can result in hyperosmolarity, renal toxicity and lactic acidosis. This is of concern in neonates given their limited metabolic capacity [1]. We therefore evaluated renal, metabolic and hepatic tolerance during PG exposure in neonates.

Methods: (pre)term neonates included in the PARANEO study (NCT00969176) received iv paracetamol PG (0.8 mg PG/mg paracetamol) for up to 48 h. Data on renal (diuresis, creatinaemia), metabolic (lactate, Anion Gap[AG]) and hepatic tolerance (AST, ALT, direct bilirubinaemia) were collected from 48 h before until 48 h after iv administration and compared with earlier reported observations on renal and hepatic tolerance during iv paracetamol (Perfalgan) exposure in neonates [2,3].

Results: Based on observations available in 40 neonates (median GA 36 wk, PNA 6 days, weight 2.5 kg) and following median PG exposure of 59 (15- 238) mg/kg, progressive postnatal normalization of creatinaemia and diuresis, lactate, BE, AG and liver enzymes was observed while sodium remained stable.

Conclusions: Median PG exposure of 59 mg/kg over 48 h did not affect postnatal adaptation and renal and hepatic observations were similar to earlier observations on iv paracetamol tolerance in neonates. We therefore conclude that this level of PG exposure seems to be well tolerated, but further studies on PG disposition and clearance are needed.

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