Hearing Loss Clinical Trial
Official title:
Auditive and Renal Long Term Outcomes - Risk After Aminoglycoside Therapy in Neonates (AURORA-study)
Gentamicin, in combination with a beta-lactam antibiotic, is commonly used for treatment of
neonatal sepsis. Neonates have a high volume of distribution. It is a paradox that most
neonatal dosing schedules still recommend lower gentamicin doses (4-5 mg/kg) than in older
children (≥ 7 mg/kg). In the neonatal unit in Tromsø a simplified gentamicin high-dose (6
mg/kg) regimen has been in use since 2004.
The investigators have previously shown that this regimen was associated with low number of
elevated trough levels, low numbers of prescription errors and no evidence for ototoxicity in
the immediate neonatal period. However, the long-term safety of gentamicin therapy in
neonates is not well studied when it comes to ototoxicity and possible nephrotoxicity.
The objective of the current study is therefore to perform a detailed hearing evaluation,
including an extended high-frequency (EHF; 9-16 kHz) audiometry, in a follow-up study of
children (participants) aged 6-15 years who were exposed to a high-dose gentamicin regimen in
the neonatal period. Moreover, we will investigate blood pressure and urine biomarkers to
assess renal tubular function. The aim is to include 250 children exposed to gentamicin in
the neonatal period and a control group of 25 healthy children.
EHF audiometry is a more sensitive method for detecting ototoxic damage and provides evidence
of ototoxicity before any hearing loss is detected by conventional systems. This is the
background for choice of method.
The primary outcome is the difference in average hearing threshold in the EHF range between
the control group and the exposed group.
Secondary outcomes are i) difference in average hearing threshold in the EHF range between
the children with gentamicin trough levels > 1.0 mg/L versus those who had lower trough
levels, ii) markers of renal tubular function (kidney injury molecule 1) and iii) blood
pressure.
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