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Auditive and Renal Long Term Outcomes - Risk After Aminoglycoside Therapy in Neonates (AURORA)

NCT03253614 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 226

Last updated 2019-03-07

No results posted yet for this study

Summary

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.

Conditions

  • Hearing Loss
  • Gentamicin Adverse Reaction
  • Renal Tubular Disorder

Interventions

DIAGNOSTIC_TEST

Audiometry

Extended high-frequency (EHF; 9-16 kHz) audiometry

DIAGNOSTIC_TEST

Urine biomarkers for renal tubular function

Kidney Injury Molecule-1

DIAGNOSTIC_TEST

Blood pressure

Blood pressure right arm, measured With standard Methods 3 times

Sponsors & Collaborators

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Claus Klingenberg, MD, PhD · University Hospital of North Norway

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2018-09-15
Completion
2018-09-15

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03253614 on ClinicalTrials.gov