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Prospective assessment of short-term propylene glycol tolerance in neonates
  1. Karel Allegaert1,
  2. Sophie Vanhaesebrouck1,
  3. Aida Kulo2,3,
  4. Katrien Cosaert4,
  5. Rene Verbesselt2,
  6. Anne Debeer1,
  7. Jan de Hoon2
  1. 1Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium
  2. 2Center for Clinical Pharmacology, University Hospitals Leuven, Leuven, Belgium
  3. 3Institute of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Sarajevo, Sarajevo, Bosnia Herzegovina
  4. 4Hospital Pharmacy, University Hospitals Leuven, Leuven, Belgium
  1. Correspondence to K Allegaert, Neonatal Intensive Care Unit, Division of Woman and Child, University Hospital, Herestraat 49, 3000 Leuven, Belgium; karel.allegaert{at}


Introduction Propylene glycol (PG) is an unintentional frequently administered solvent in neonates despite the fact that PG accumulation potentially results in hyperosmolarity, lactic acidosis and renal/hepatic toxicity.

Methods Prospective evaluation of renal (diuresis, creatinaemia, sodium), metabolic (base excess, anion gap, lactate, bicarbonate) and hepatic (alanine transaminase, aspartate aminotransferase, direct bilirubinaemia) tolerance to PG in (pre)term neonates following intravenous administration of formulations (paracetamol, phenobarbital, digoxin) that contain PG. Observations from 48 h before up to 48 after the last PG administration were described and compared (paired analysis). Clinical characteristics and observations collected following intravenous PG-paracetamol administration were compared with a historical cohort of neonates in whom similar (renal, hepatic) observations during exposure to a mannitol-containing paracetamol formulation were collected.

Results 5566 observations were collected in 69 neonates before, during and following median PG exposure of 34 mg/kg/24 h (range 14–252). Progressive postnatal adaptation in renal, metabolic and hepatic function was documented, unrelated to the PG exposure. In the subgroup of 40 cases treated with intravenous PG-paracetamol, observations on renal and hepatic function were similar to a historical cohort of published observations following exposure to intravenous mannitol-paracetamol.

Conclusions Unintended PG administration (34 mg/kg/24 h) for a maximum of 48 h seems to be tolerated in (pre)term neonates and does not affect short-term postnatal adaptations. Further studies on PG disposition and the level of safe exposure to PG, including long-term safety data in neonates are needed.

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  • Funding The clinical research of KA is supported by the Fund for Scientific Research, Flanders (Belgium) (FWO Vlaanderen), by a Fundamental Clinical Investigatorship (1800209 N).

  • Competing interests None.

  • Ethics approval The study was conducted in Leuven NICU following approval by the local ethical board of the University Hospitals Leuven (B-32220084836).

  • Provenance and peer review Not commissioned; externally peer reviewed.