Determination of Gentamicin Dosing in Neonatal Patients

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]

The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• infants w/o culture proven sepsis