Codeine in Mechanically Ventilated Neonates
Completed · Phase 1
Conditions studied: Mechanically Ventilated Neonates, Painful Procedures in Newborns
In brief
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.
Key facts
- Study ID
- NCT01322204
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 6
- Starts
- 2008-08-01
- Expected to finish
- 2013-03-06
- Last updated by the study team
- 2018-08-27
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Neonates ≥ 26 weeks PCA receiving mechanical ventilation and painful procedure will be eligible for participation in the study
- Subject's parent/legal guardian must give written informed consent prior to study participation
- Subject is receiving opioid analgesia therapy based on caregiver determination. The ideal patient will not be receiving morphine.
- Must be able to receive an enteral dose of codeine.
You may not qualify if…
- Known hypersensitivity to morphine, fentanyl, or codeine
- Patients with ALT concentrations >2x upper limit of normal for age or clinical evidence of hepatic failure
- Patients with serum creatinine concentrations >2x upper limit of normal for age or clinical evidence of renal failure
- Patients who are NPO
- Babies born to maternal drug abuse.
- Total serum bilirubin level of > 10 mg/dl or 170 umol/L.
Where it is running
- State University of New York Downstate — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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