Antibiotic Use in a Cohort of Extremely Low Birth Weight Neonates: Focus on Off-Label Uses and Prescription Behaviour

In the last decades, the survival of extremely low birth weight (ELBW) neonates (BW ≤ 1000 g) has improved dramatically due to advances in perinatal and neonatal care and better understanding of their physiopathology. These neonates, characterized by a great immaturity, are more exposed to risks to develop different morbidities and in particular are vulnerable to bacterial and fungal infections.

Antibiotics are medications used to fight infections caused by bacteria. Nowadays, a large variability in the use of antibiotics for the treatment of suspected/confirmed neonatal sepsis persists between different European Neonatal Intensive Care Units (NICUs) and most agents are still used in an off-label (OL) manner. In this paper, the authors aimed to analyze antibiotic prescriptions in a cohort of extremely low birth weight neonates admitted to Italian level III Neonatal intensive Care Units. 

An online questionnaire was used to collect detailed information for each newborn. Antibiotic prescriptions were classified about their license status and compared with British National Formulary for Children (BNFC) and with a practical guide prepared by the Italian Society of Neonatology (ISN). Data were collected in a database and summarized using standard descriptive methods.

During the study period (May - July 2014) among 93 neonates admitted to 30 Italian Neonatal intensive Care Units, 56 (60%) received at least an antibiotic (92 prescriptions in total). Ampicillin, gentamicin and vancomycin were the antibiotics most commonly used for the prevention/treatment of bacterial infections. 56/92 antibiotic prescriptions (61%) resulted off-label mainly as regards dosing frequency, while 13 prescriptions (14%) regarded antibiotics used in absence of specific indication for newborns (meropenem, imipenem, piperacillin/tazobactam, clindamycin, clarithromycin). 50/56 neonates (89.3%) received at least one off-label antibiotic prescription. Differences have been observed in dosing regimens between current study and recommendations contained in BNFC, while prescriptions adhered more frequently to ISN indications. 

In summary, our results confirm the high prevalence of off-label antibiotic use in ELBW neonates and underline a better adherence to indications based on clinical practice.

Article by Laura Cuzzolin and Rocco Agostino, from Italy.

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