Pharmacokinetic study of Amikacin in Neonates
Not Applicable
- Conditions
- Health Condition 1: P228- Other respiratory distress of newborn
- Registration Number
- CTRI/2019/10/021750
- Lead Sponsor
- Manipal academy of higher education
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Neonates prescribed with Amikacin
Neonates whose blood samples were sent for routine investigations
Exclusion Criteria
Preterm neonates
Neonates who are clinically unstable
Neonates whose parents/guardians unable or unwilling to give consent.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Amikacin concentrations will be estimated from blood plsama <br/ ><br>2. clinical and nonclinical factors influencing the amikacin kinetics in neonates will be studied <br/ ><br>3. population pharmacokinetic model will be developed for amikacin in neoneates.Timepoint: 1.amikcin concentration will be estimated once in every 3 months <br/ ><br>2. factors influencing amikacin kinetics will be started to analyze after 6 months <br/ ><br>3. population pharmacokinetics model will be developed with in 36 months from the initiation of study
- Secondary Outcome Measures
Name Time Method 1.To identify the co-variates affecting amikacin clearance in neonates.Timepoint: 1. covarite analysis will be started after 1 year