Modelling of saliva gentamicin concentrations in neonates receiving gentamicin treatment

Completed

• Conditions: antibiotic treatment; 10004018

• Registration Number: NL-OMON48679
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Gentamicin treatment
Admission to the neonatology ward , pediatrics/pediatric surgery department,
obstetrics department or maternity ward of the AMC/Juliana children*s hospital
(Haga Hospital)
Signed informed consent from both parents prior to any study-mandated procedure

Exclusion Criteria

Congenital disease of the salivary glands
Parent refusal
Inability to sample saliva

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study paramters are the saliva gentamicin concentrations at different<br /><br>time-points.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters of this study are gentamicin concentrations in<br /><br>plasma, correlation between plasma and saliva gentamicin, citric acid<br /><br>stimulation during saliva sampling (Y/N), sampling duration, salivary pH and<br /><br>sample volume.</p><br>