Determination of Gentamicin Dosing in Neonatal Patients
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The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.
Condition or disease
Drug: Gentamicin in Uniject Pre-filled syringe
This study aims to verify dosages of gentamicin for use in Uniject, chosen based on a consideration of gentamicin pharmacokinetics, safety, efficacy, target population body weight, cost, feasibility and acceptability.
Determination of Gentamicin Dosing in Neonatal Patients for Use in the Uniject Pre-filled Syringe [A Three-site Study at: 1) Dhaka Shishu Hospital, Dhaka Bangladesh; 2) Christain Medical Center, Vellore, India; and 3) Aga Khan University Medical Center, Karachi, Pakistan]
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
up to 28 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
infants with culture proven sepsis
infants 2000-2499 at birth
infants > 2500 gm at birth
infants < 2000 gm at birth
in study site areas: Pakistan, Bangladesh and India