- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01322204
Codeine in Mechanically Ventilated Neonates
Absorption and Metabolism of Oral Codeine in Mechanically Ventilated Neonates
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
This proposal has its origins in a larger initiative to elucidate the pharmacological basis for the interindividual differences observed in opioid responsiveness. Gaps in our knowledge related to opioid disposition in newborns need to be addressed to complete the design of the required overarching initiative in which age could be treated as a continuous variable within a context of PK, PD and PG determinants.This proposal is designed to generate preliminary data that addresses two issues. First, can newborns absorb enterally administered codeine and is this ability determined by PCA or PNA age? The second relates to the ability of newborn infants to catalyze those reactions required to metabolically activate both codeine and morphine. The latter will also be evaluated within the context of PCA versus PNA age.
These data will not only fill an information gap that must be addressed before the larger initiative moves forward, but they also provide a platform for serious study of the ontogeny of certain pharmacokinetic processes that may prove critical to our understanding of newborn drug disposition. In this way, codeine can provide important insights concerning the ontogeny of drug disposition and permit the determination of the relative importance of PCA versus PNA ages to the functional expression of these processes.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
New York
-
Brooklyn, New York, Förenta staterna, 11203
- State University of New York Downstate
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 1
Neonates 0-30 days, no more than 2,000 grams, receiving mechanical ventilation.
|
One single oral dose of 1 mg/kg of codeine
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The rate and extent of absorption of oral codeine, the ratios of the observed concentration of each metabolite to the observed concentration of parent drug and the formation and clearances of the metabolites.
Tidsram: 2 hours
|
2 hours
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Secondary outcomes include the additional PK parameters elimination half life, area under the curve and mean residence time.
Tidsram: 2 hours
|
2 hours
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Jacob V Aranda, MD, PhD, State University of New York Downstate
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10922
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