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Pharmacokinetic study of Amikacin in Neonates

Population Pharmacokinetics of Amikacin during Therapeutic Hypothermia in Neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/10/021750
Enrollment
90
Registered
2019-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P228- Other respiratory distress of newborn

Interventions

None listed

Sponsors

Manipal academy of higher education
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates prescribed with Amikacin Neonates whose blood samples were sent for routine investigations

Exclusion criteria

Exclusion criteria: Preterm neonates Neonates who are clinically unstable Neonates whose parents/guardians unable or unwilling to give consent.

Design outcomes

Primary

MeasureTime frame
1. Amikacin concentrations will be estimated from blood plsama 2. clinical and nonclinical factors influencing the amikacin kinetics in neonates will be studied 3. population pharmacokinetic model will be developed for amikacin in neoneates.Timepoint: 1.amikcin concentration will be estimated once in every 3 months 2. factors influencing amikacin kinetics will be started to analyze after 6 months 3. population pharmacokinetics model will be developed with in 36 months from the initiation of study

Secondary

MeasureTime frame
1.To identify the co-variates affecting amikacin clearance in neonates.Timepoint: 1. covarite analysis will be started after 1 year

Countries

India

Contacts

Public ContactMatcha Saikumar

Manipal college of pharmaceutical sciences

msv.rajan@manipal.edu9886921414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026