drugset / Trial / NCT01322204

Codeine in Mechanically Ventilated Neonates

NCT01322204

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the absorption and bioavailability of codeine in relation to postnatal (PNA) and postconceptional (PCA) age; determine the parent drug (codeine), its active metabolites, their formation rates and their ratios in relation with PCA and PNA; and identify relevant genetic polymorphisms of opioid metabolism in the study population and their potential relationship to the biodisposition and pharmacodynamic effects of codeine. The study population is intubated and mechanically ventilated infants equal to or greater than 26 weeks gestational age at birth and less than 4 weeks postnatal age.

Timeline

Start
2008-08
Primary completion
2013-03-06
Completion
2013-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Codeine Small molecule 1 mg/kg Oral