Health Condition 1: A488- Other specified bacterial diseases
Conditions
Interventions
None listed
Sponsors
All India Council for Technical Education
Manipal Academy of Higher Education
Eligibility
Inclusion criteria
Inclusion criteria: I. Neonates with more than 32 weeks of gestational age (GA) and less than 31 days of postnatal age (PNA) and receiving selected drugs. II. Neonates whose blood sample are being sent for routine laboratory investigations.
Exclusion criteria
Exclusion criteria: I. Clinically unstable neonates. II. Neonates whose parents/guardians are unwilling/ unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Method will be developed and validated for estimation of Drug concentrations in blood (using plasma / DBS).Timepoint: I. Drug estimation from the collected DBS/plasma sample will be done once in 3 months of time. II. Factor influencing PK profile of drug will be analyzed in 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters will be used for developing optimal dosage regimen individualized dose calculation for neonatal population including intra uterine growth restriction (IUGR) babies to optimize the dose regimen.Timepoint: Population pharmacokinetics model and physiologically based pharmacokinetics model will be developed in 36 months from the initiation of study. | — |
Countries
India
Contacts
Public ContactBhim Bahadur Chaudhari
Manipal College of Pharmaceutical Sciences, MAHE
Outcome results
None listed