Modelling of saliva gentamicin concentrations in neonates receiving gentamicin treatment

• Conditions: Neonatal infection; Neonatal sepsis; 10004018

• Registration Number: NL-OMON31541
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

•Term or preterm infants with a postnatal age <= 28 days
•Receiving treatment with gentamicin
•Written informed consent from parents having parental responsibility or from the legal guardian.

Exclusion Criteria

•Infant suspected of or suffering from necrotizing enterocolitis

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Description of the concentration-time profile of saliva gentamicin levels in<br /><br>neonates.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The development of a valid population PK model which can predict serum<br /><br>gentamicin concentrations based on gentamicin concentrations in saliva.<br /><br><br /><br>If a fitting model is obtained: assessment of the dosing advice that a hospital<br /><br>pharmacist would come to based on serum gentamicin concentrations predicted by<br /><br>the model.</p><br>