Gentamicin in Newborn Sepsis: Once Daily Dose versus Twice Daily Dose

Chandan Kumar Shaha,Md Shahidullah,Abdul Mannan,Sanjoy Kumar Shaha,Shadeka Chowdhury Moni,Mohammad Kamrul Hassan Shabuj

doi:10.3329/bmrcb.v43i2.35188

Chandan Kumar Shaha, Md Shahidullah + Show 4 more

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https://doi.org/10.3329/bmrcb.v43i2.35188

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Abstract

Gentamicin is commonly used as first line drug in neonatal sepsis. It is usually used in combination with other drugs. It is a nephrotoxic and an ototoxic drug. Long term use causes renal failure and hearing impairment. Its efficacy depends on the peak concentration, and its toxicity is related to the trough concentration. There is no set protocol of using gentamicin in neonate in Bangladesh, whether it should be used once daily or twice, it is till debatable in this perspective. In daily practice, it is not followed up trough and peak concentration of gentamicin, so it is not known the renal and hearing status of the baby treated with aminoglycosides. In this regard, primary objectives were to measure the peak level (to observe efficacy) and trough (to observe toxicity) level of gentamicin in once-daily dose (ODD) and in twice-daily dose (TDD) of gentamicin in neonates treated for suspected or culture proven sepsis and finally to assess the renal status and hearing status. This was an open label clinical trial, conducted in the Neonatal Intensive Care Unit, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, during the period of March, 2012 to November, 2012. A total of 50 neonates were included in the study, 25 in ODD group and 25 in TDD group of gentamicin. Serum gentamicin peak and trough were measured in both groups. Mean gestational age were 38.85±1.21Wk and 38.83±1.16Wk in ODD and TDD respectively, and their corresponding mean weights were 2341.66±377 gram and 2307±363 gram. Only a fraction (12 % in ODD group 20% in TDD group) of patients had culture positive sepsis. The mean peak concentration of gentamicin was significantly higher (p value < 0.001) among neonates who received once-daily dose (7.19±1.7 microgram/ml) compare to patients who received the twice-daily dose (4.81±1.8 microgram/ml). The mean trough concentration of gentamicin was significantly lower (p value = 0.04) among neonates who received once-daily dose (1.5±0.78) compared to patients who received the twice-daily dose (2.00±0.9). Serum creatinine concentration raise was statistically non-significant in both group. Only 4% in ODD and 8% in TDD had ototoxicity which was non-significant finding. It may be concluded that ODD of gentamicin had significant higher concentration of peak and lower trough concentration, but no significant difference was in serum creatinine concentration and ototoxicity.

Highlights

Neonatal sepsis is one of the most common causes of neonatal morbidity and mortality in the preterm population.1Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteraemia in the first month of life
This open label clinical trial was conducted in the Neonatal Intensive Care Unit (NICU), Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, during the period of March to November, 2012
Peak level of gentamicin is the maximum concentration within 30 minutes to one hour after injection and expected concentration is to be 5 to 10 microgram /ml and trough level is the concentration of gentamicin that is measured before giving the doe it must be

Summary

Introduction

Neonatal sepsis is one of the most common causes of neonatal morbidity and mortality in the preterm population.1Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteraemia in the first month of life. It encompasses various systemic infections of the newborn such as septicaemia, meningitis, pneumonia, arthritis, osteomylitis and urinary tract infections.[2] The World Health Organization (WHO) estimates that 1 million deaths per year (10% of all under-five mortality) are due to neonatal sepsis and 42% of these deaths occur in the first week of life. This study was aimed to asses peak and trough concentration of gentamicin, and to asses renal function by measuring serum concentration of creatinine and ototoxicity by doing Otoacoustic emission (OAE)

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