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Excipient exposure in very low birth weight preterm neonates
T O Akinmboni1, N L Davis1, A J Falck1
1Division of Neonatology, Department of Pediatrics, University of Maryland School of Medicine, Baltimore MD, USA.
Summary
Most very low birth weight (VLBW) neonates receive medications with excipients like benzyl alcohol, propylene glycol, and ethanol. Some VLBW infants receive doses exceeding adult recommendations, highlighting the need for careful medication management.
Area of Science:
- Neonatal pharmacology
- Pediatric intensive care
- Drug safety
Background:
- Benzyl alcohol, propylene glycol, and ethanol are common excipients in neonatal intensive care unit (NICU) medications.
- High-level exposure to these excipients can pose risks to the vulnerable neonatal population.
- Limited data exists on specific excipient exposure levels in very low birth weight (VLBW) neonates.
Purpose of the Study:
- To quantify the exposure of VLBW neonates to common pharmaceutical excipients.
- To identify clinical factors associated with increased excipient exposure in VLBW neonates.
- To inform safe medication practices for VLBW infants.
Main Methods:
- Retrospective review of medical records for VLBW infants over a one-year period.
- Calculation of individual excipient exposures based on medication administration records.
- Multivariable regression analysis to identify predictors of higher excipient exposure.
Main Results:
- Nearly all VLBW infants (98%) were exposed to at least one excipient.
- A significant proportion (5-9%) received excipient doses exceeding adult recommended levels.
- Conditions such as necrotizing enterocolitis, seizures, bronchopulmonary dysplasia, and prolonged hospital stay were associated with higher excipient exposure.
Conclusions:
- Commonly prescribed medications for VLBW neonates contain excipients that can lead to cumulative doses exceeding adult safety limits.
- The safety profiles of these excipients in neonates are not well-established.
- Judicious use of medications containing benzyl alcohol, propylene glycol, and ethanol is recommended for VLBW infants, necessitating careful monitoring and dose consideration.
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