Asia Pacific Journal of Medical Toxicology

Once vs. Twice Daily Gentamicin Therapy in Neonates: a Comparison of Its Induced Nephro- and Ototoxicity

Document Type : Original Article

Authors

Ahmadshah Farhat 1
Ashraf Mohammadzadeh 1
Ezzat Khodashenas 1
Abbas Alizadeh 1
Nazli Parizadeh 2

1 Neonatal Research Center, Pediatric Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

2 Pediatric and Congenital Cardiology Division, Pediatric Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

https://doi.org/10.22038/apjmt.2025.91568.1537
Abstract
Background: Gentamicin is a commonly used antibiotic in neonatal intensive care units with known renal and auditory toxic effects. Several studies have aimed to reduce these adverse effects, which are mainly related to dosage and infusion rate. Reducing the frequency of gentamicin injections may save time, money, and human resources. This study aimed to compare the toxic effects of gentamicin administered once daily versus twice daily in neonates.  
Methods: All neonates hospitalized in the NICU who met eligibility criteria and were receiving gentamicin therapy were recruited using a non-random, target-based sampling method. Participants were randomly assigned to two groups: group A received gentamicin once daily,   and group B twice daily. Therapeutic efficacy, nephrotoxicity, ototoxicity, and mortality rates were compared between the groups based on clinical evaluation, laboratory data, and  audiometric tests. Serum urea and creatinine levels were assessed to evaluate nephrotoxicity, while otoacoustic emissions (OAE) and automated auditory brainstem response (AABR) tests were used to assess ototoxicity.
Results: Therapeutic effectiveness and nephrotoxicity were similar between the groups. Audiometric tests were normal in group A, whereas 6 patients in group B showed abnormal OAE and AABR results, which was statistically significant (P=0.012). No neonatal deaths occurred in either group.
Conclusion: Once-daily gentamicin administration results in fewer audiological side effects compared to twice-daily dosing, highlighting its importance in reducing toxicity and conserving resources.

Keywords

Gentamicin
Neonate
Toxicity
Subjects
  1. Lawn JE, Cousens S, Zupan J. 4 million neonatal deaths: When? Where? Why? Lancet 2005; 365:891-900.
  2. Saving Newborn Lives. State of the world’s newborns. Washington, DC: Save the Children Federation, 2001. 28 p.
  3. Baqui AH, Darmstadt GL, Williams EK, Kumar V, Kiran TU, Panwar D et al. Rates, timing, and causes of neonatal deaths in rural India: implications for neonatal health programmes. Bull World Health Organ 2006;84:706-13.
  4. Lawn J, Shibuya K, Stein C. No cry at birth: global estimates of intrapartum stillbirths and intrapartum-related neonatal deaths. Bull World Health Organ 2005;83:409-17.
  5. Stoll BJ. The global impact of neonatal infection. Clin Perinatol 1997;24:1-21.
  6. World Health Organization. Management of the child with serious infection or severe malnutrition: guidelines for care at the first-referral level in developing countries. Geneva: World Health Organization, 2000:74-9. (WHO/FCH/CAH/00.1).
  7. Stoll BJ. Neonatal infections: a global perspective (chapter 3). In: Remington JS, Klein JO, editors. Infectious diseases of the fetus and newborn infant. 5th ed. Philadelphia, PA: Saunders, 2001:139-68.
  8. World Health Organization. Essential newborn care. Report of a Technical Working Group, Trieste, April 25-29, 1994. Geneva: World Health Organization, 1996. 19, p (WHO/FRH/MSM/96.13). (http://www.alianzaipss.org/reproductive- health/publications/MSM_96_ 13/MSM_96_13_Chapter1.en.html, accessed on 19 May 2008).
  9. Sonntag J, Prankel B, Waltz S. Serum creatinine concentration, urinary creatinine excretion and creatinine clearance during the first 9 weeks in preterm infants with a birth weight below 1500 g. Eur J Pediatr 1996;155:815-9.
  10. Vanpee M, Ergander U, Herin P, Aperia A. Renal function in sick, very low-birth-weight infants. Acta Paediatr 1993; 82:714-8.
  11. Krishnan L, George SA. Gentamyicin therapy in preterms: a comparison of two dosage regimens. Indian Pediatr 1997; 34:1075-80.
  12. Kasalaraksa P, Janthep P, Jirapradittha J, Taksaphan S, Kiatchoosakun P. Once versus twice dose of Gentamicin therapy in Thai neonates. J Med Assoc Thai 2004; 87(4): 372-6.
  13. Solomon R, Kuruvilla KA, Job V, Selvakumar R, Jeyaseelan L, Kanagasabapathy AS, et al. Randomized controlled trial of once vs. twice daily gentamicin therapy in newborn. Indian Pediatr 1999; 36:133-7.
  14. Chotigeat U, Narongsanti A, Ayudhya DP. Gentamicin in neonatal infection: once versus twice daily dosage. J Med Assoc Thai 2001;84:1109-15.
  15. Kiatchoosakun P, Kosalaraksa P, Jirapradittha J, Taksaphan S, Tassniyom S. Once-daily gentamicin dosing of 4 mg/kg/dose in neonates. J Med Assoc Thai 2005;88:934-8.
  16. Contopoulos-Ioannidis D, Giotis N, Baliatsa D, Ioannidis J. Extended-interval aminoglycoside administration for children: a meta-analysis. Pediatrics 2004;114(1):e111-8.
  17. Langhendries J.P, Battisti O, Bertrand J M , Francois A , Darimont J , Ibrahim S , et al. Once-a-day administration of amikacin in neonates: assessment of nephrotoxicity and ototoxicity. Dev Pharmacol Ther. 1993;20(3-4):220-30
Asia Pacific Journal of Medical Toxicology
Volume 14, Issue 4
Autumn 2025
Pages 151-154

Home

Guide for Authors

Submit Manuscript

Reviewers

Contact Us