Codeine in Mechanically Ventilated Neonates
Absorption and Metabolism of Oral Codeine in Mechanically Ventilated Neonates
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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New York
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Brooklyn、New York、アメリカ、11203
- State University of New York Downstate
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
Neonates 0-30 days, no more than 2,000 grams, receiving mechanical ventilation.
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One single oral dose of 1 mg/kg of codeine
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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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.
時間枠：2 hours
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2 hours
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Secondary outcomes include the additional PK parameters elimination half life, area under the curve and mean residence time.
時間枠：2 hours
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2 hours
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協力者と研究者
捜査官
- 主任研究者：Jacob V Aranda, MD, PhD、State University of New York Downstate
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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