Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates (NeoPopGen)
Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations
Children differ from adults with respect to growth and development but also immaturity of various pharmacological mechanisms. Dosing schemes in children are usually derived in an empirical manner from clinical trials in adult patient groups. All this poses neonates to an increased risk for therapeutic failure and adverse drug reactions.
Medicinal products studied during this project are among the ones with the highest needs for research in the pediatric intensive care. This project focuses on the necessity to integrate subject's individual characteristics to assist clinical decision-making in drug therapy. The investigators explore the mechanisms defining the dose response in pediatric populations. The results obtained with these studies will help to find safer drug dosing regimens in this delicate patient population.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Turku、フィンランド、20521
- Department of Paediatrics and Adolescent Medicine, Turku University Hospital
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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:
- Given informed consent by the guardian of an eligible patient.
- Patient is more than 24 weeks old and has a body weight more than 500 g.
- Patient needs intensive care treatment based on a clinical decision by a neonatologist and receives propofol or oxycodone on their therapy. Attending neonatologist makes the decision to prescribe propofol for scheduled short procedural sedation or oxycodone for analgesia as well as all other treatment related decisions.
Exclusion Criteria:
- Eligible patients guardian declines to give informed consent.
- A previous history of intolerance to the study drugs or to related compounds and additives.
- History of any kind of drug allergy.
- Participation in any other studies concomitantly or within one month prior to the entry into this study.
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：非ランダム化
- 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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アクティブコンパレータ：Propofol
Plasma samples and patient data are collected prospectively from 40 neonates who receive propofol as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
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アクティブコンパレータ：Oxycodone
Plasma samples and patient data are collected prospectively from 40 neonates who receive oxycodone as part of their care in the neonatal intensive care unit at the Turku University Hospital, Turku, Finland.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.
時間枠：24 hours post-dose.
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Primary outcome is to build up a population pharmacometric model to describe pharmacokinetics of propofol and oxycodone based on drug concentrations analyzed from the plasma samples.
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24 hours post-dose.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effect of biometric and genomic covariates on AUC
時間枠：24 hours post-dose
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Covariate analysis and simulations to individualize population models
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24 hours post-dose
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Efficacy of propofol in procedural anesthesia in neonates
時間枠：24 hours
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability during procedural anesthesia for intratracheal intubation in neonates
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24 hours
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Efficacy of oxycodone as an analgesic in neonates during mechanical ventilation
時間枠：24 hours
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability in neonates after oxycodone administration during mechanical ventilation.
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24 hours
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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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