EUCTR2011-000310-19-SE进行中（未招募）不适用
Fentanyl treatment in newborn infants: A Pharmacokinetic, Pharmacodynamic, and Pharmacogenetic Study (PK/PD model) - NeoFent I
und University0 个研究点目标入组 180 人开始时间: 2011年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Clinical indication (or pain scoring, see 7.2.1: PIPP = 7, or BIIP = 3, or EDIN = 6) for analgesia before any of following procedure:
- •a.Insertion of peripheral IV-catheter
- •b.Insertion of arterial cannula
- •c.Other skin breaking procedure
- •d.Insertion of chest tube
- •Other painful/stressful procedure might be considered if indicated by pain scoring used, eg. endotracheal suction.
- •2.Possibility to obtain blood sample after the procedure (indwelling line or the procedure is insertion of line as clinically indicated)
- •3.Infants of all gestational ages (preferably preterm born at a gestational age of 24 0/7 to 32 6/7 weeks and term infants at 38-41 gestational weeks (gw) for the first 65 in the PK/PD model)
- •4.Postnatal age 0-28 days, ie up to an age corresponding to 44 post conceptional weeks.
- •5.Informed written parental consent.
- •The infants will be analyzed in five postconceptional age groups and the target number of infants are:
- •23-26 gwn= 20
- •27-28 gwn= 30
- •29-32 gwn= 40
- •33-36 gw n= 40
- •37-42 gwn= 50
- •The same infant can be included for another painful procedure after at least 2 weeks interval, ie when has reached the next gestational age group. In total maximum three series of blood sampling, according to weight.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Concurrent or previous other opioid administration:
- •a. for morfine a 72 h interval required
- •b. for remifentanil a 6 h interval required
- •c. for alfentanil a 24 h interval required
- •d. (previous fentanyl administration is NOT an exclusion criterion, but baseline concentration needed before study drug administered)
- •2.Abdominal surgery (since intra-abdominal pressure influences fentanyl metabolism)
- •3.Major chromosomal anomaly, e.g. trisomy
- •4.Neonatal encephalopathy (e.g. seizures, lethargy/coma)
- •5.Use of muscular relaxant
- •6.Hypothermia treatment after hypoxic-ischemic insult
- •7.Clinical or biochemical evidence of hepatic failure (e.g. cholestasis, hepatic coagulopathy, hypoalbuminaemia) or renal failure (serum creatinine > 132 micro mol/L corresponding to >1.5 mg/dL42)
- •8.Participation in other clinical intervention trial (including blood sampling procedures other than clinical routine, and administration of other investigational medicinal product) within 72 hours before study start and throughout the study
研究者
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