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.
연구 개요
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Turku, 핀란드, 20521
- Department of Paediatrics and Adolescent Medicine, Turku University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Area under the plasma concentration versus time curve (AUC) of propofol and oxycodone.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Effect of biometric and genomic covariates on AUC
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- T65/2015
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