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Ototoxic and nephrotoxic drugs in neonatal intensive care units: results of a Spanish and Italian survey

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Abstract

Neonates face heightened susceptibility to drug toxicity, often exposed to off-label medications with dosages extrapolated from adult or pediatric studies. Premature infants in Neonatal Intensive Care Units (NICUs) are particularly at risk due to underdeveloped pharmacokinetics and exposure to multiple drugs. The study aimed to survey commonly used medications with a higher risk of ototoxicity and nephrotoxicity in Spanish and Italian neonatal units. A prospective cross-sectional study was conducted in Italian and Spanish neonatal units using a web-based survey with 43 questions. A modified Delphi method involved experts refining the survey through online consensus. Ethical approval was obtained, and responses were collected from January to July 2023. The survey covered various aspects, including drug-related ototoxic and nephrotoxic management, hearing screening, and therapeutic drug monitoring. Responses from 131 participants (35.9% from Spain and 64.1% from Italy) revealed awareness of drug toxicity risks. Varied practices were observed in hearing screening protocols, and a high prevalence of ototoxic and nephrotoxic drug use, including aminoglycosides (100%), vancomycin (70.2%), loop diuretics (63.4%), and ibuprofen (62.6%). Discrepancies existed in guideline availability and adherence, with differences between Italy and Spain in therapeutic drug monitoring practices.

Conclusions:The study underscores the need for clinical guidelines and uniform practices in managing ototoxic and nephrotoxic drugs in neonatal units. Awareness is high, but inconsistencies in practices indicate a necessity for standardization, including the implementation of therapeutic drug monitoring and the involvement of clinical pharmacologists. Addressing these issues is crucial for optimizing neonatal care in Southern Europe.

What is Known:

• Neonates in intensive care face a high risk of nephrotoxicity and ototoxicity from drugs like aminoglycosides, vancomycin, loop diuretics, and ibuprofen.

• Therapeutic drug monitoring is key for managing these risks, optimizing dosing for efficacy and minimizing side effects.

What is New:

• NICUs in Spain and Italy show high drug toxicity awareness but differ in ototoxic/nephrotoxic drug management.

• Urgent need for standard guidelines and practices to address nephrotoxic risks from aminoglycosides, vancomycin, loop diuretics, and ibuprofen.

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Data availability

The data presented in this study are available on request from the corresponding author.

Abbreviations

a-ABR:

Automated Auditory Brainstem Response

AKI:

Acute kidney injury

a-OAE:

Automated Oto-Acoustic Emissions

CKD:

Chronic kidney disease

CYP:

Cytochromes P450

D-AKI:

Drug-induced acute kidney injury

ECMO:

Extracorporeal membrane oxygenation

JCIH:

Joint Committee on Infant Hearing

NICU:

Neonatal intensive care unit

PICU:

Pediatric intensive care units

SENeo:

Spanish Society of Neonatology

SIN:

Italian Society of Neonatology

TDM:

Therapeutic drug monitoring

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Acknowledgements

A special thanks to all members of the Segurneo Committee of the Spanish Neonatal Society (SENeo), the Neonatal Pharmacotherapy Study Group, the Neonatal Nephrology Study Group, and the Sense Organ Study Group of the Italian Society of Neonatology (SIN).

Funding

This study was (partially) supported by the Italian Ministry of Health (Ricerca Corrente).

Author information

Author notes

  1. Cristina Arribas and Nunzia Decembrino are co-first author Giacomo Cavallaro and Felipe Garrido are co-last author contributed equally to this work.

Authors and Affiliations

  1. Neonatal Intensive Care Unit, Clínica Universidad de Navarra, 28027, Madrid, Spain

    Cristina Arribas & Felipe Garrido

  2. Neonatal Intensive Care Unit, AOU Policlinico G. Rodolico San Marco, 95123, Catania, Italy

    Nunzia Decembrino

  3. Neonatal Intensive Care Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, 20122, Milan, Italy

    Genny Raffaeli, Ilaria Amodeo, Gabriella Araimo, Fabio Mosca & Giacomo Cavallaro

  4. Department of Statistics and Operations Research, Faculty of Medicine, University of Cadiz, 11003, Cádiz, Spain

    Juan Luis González-Caballero

  5. Department of Pediatrics, Clínica Universidad de Navarra, 31008, Pamplona, Spain

    Mónica Riaza

  6. Neonatal Intensive Care Unit, Hospital Universitario Puerta de Hierro-Majadahonda, 28222, Madrid, Spain

    Roberto Ortiz-Movilla

  7. Neonatal Intensive Care Unit, Ospedale Regionale Di Bolzano, 39100, Bolzano, Italy

    Luca Massenzi

  8. Division of Pediatrics and Neonatology, Sandro Pertini Hospital, 00157, Rome, Italy

    Camilla Gizzi

  9. Division of Pediatrics and Neonatology, ASST del Garda, 25015, Desenzano del Garda (BS), Italy

    Donatella Cattarelli

  10. Neonatal Intensive Care Unit, Children’s Hospital, ASST Spedali Civili, 25123, Brescia, Italy

    Salvatore Aversa

  11. Neonatal Intensive Care Unit, ASST Grande Ospedale Metropolitano Niguarda, 20162, Milan, Italy

    Stefano Martinelli

  12. Division of Neonatology, Area of Child Health, Department of Woman, Child Health and Public Health, Fondazione IRCCS Policlinico Universitario Agostino Gemelli, 00168, Rome, Italy

    Simonetta Frezza

  13. Neonatal Intensive Care Unit, Isola Tiberina Hospital Gemelli Isola, 00186, Rome, Italy

    Luigi Orfeo

  14. Department of Clinical Sciences and Community Health, Università Degli Studi Di Milano, 20122, Milan, Italy

    Fabio Mosca

Authors
  1. Cristina Arribas
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  2. Nunzia Decembrino
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  18. Felipe Garrido
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Consortia

On behalf of the Segurneo Committee of the Spanish Neonatal Society (SENeo), the Neonatal Pharmacotherapy Study Group, the Neonatal Nephrology Study Group, the Sense Organ Study Group of the Italian Society of Neonatology (SIN)

Contributions

CA, ND, GR, IA, GA, GC, and FG contributed to the study’s conception and design. CA, ND, GR, IA, GA, GC, LM, DC, SA, SM, SF, and FG contributed to the study’s methodology, investigation, and data curation. GC, GA, SM, SA, SF, LM, DC, and FG contributed to the study’s validation, formal analysis, and resources. JG and FG performed the statistical analysis. CA, ND, GR, GC, and FG wrote the original draft preparation of the manuscript. The co-first CA and ND, and co-last GC and FG authorship contributed equally and have the right to list their name as first or last in their Curriculum Vitae. CA, ND, GR, IA, GA, GC, LM, MR, RO, CG, DC, DC, SA, SM, SF, LO, FM, and FG wrote, reviewed, and edited the manuscript. FG and GC contributed equally to the visualization of the manuscript. GC and FG contributed to the supervision and project administration of the study.

Corresponding author

Correspondence to Genny Raffaeli.

Ethics declarations

Competing interests

The authors declare no competing interests.

Institutional review board statement

The study, complying with the Helsinki Declaration, was approved by the University of Navarra Ethics Committee (CEI UNAV) with code 2023.189. Participants’ submission of surveys was deemed as consent to participate, aligning with the Institutional Review Board’s indications.

Additional information

Communicated by Daniele De Luca

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Arribas, C., Decembrino, N., Raffaeli, G. et al. Ototoxic and nephrotoxic drugs in neonatal intensive care units: results of a Spanish and Italian survey. Eur J Pediatr 183, 2625–2636 (2024). https://doi.org/10.1007/s00431-024-05467-w

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