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临床试验/EUCTR2009-011753-41-NL
EUCTR2009-011753-41-NL
进行中(未招募)
不适用

Pain treatment of newborns: paracetamol rectal versus intraveneous administration, an open randomised clinical trial. - Pain treatment of newborns: paracetamol rectal versus intraveneous administration.

eonatal intensive care unit, VU medical center Amsterdam0 个研究点目标入组 0 人2010年12月28日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
未指定
发起方
eonatal intensive care unit, VU medical center Amsterdam
状态
进行中(未招募)
最后更新
14年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2010年12月28日
结束日期
待定
最后更新
14年前
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

发起方
eonatal intensive care unit, VU medical center Amsterdam

入排标准

入选标准

  • Gestational age \> 26 weeks
  • Weight at birth for gestational age \< p97
  • necessity for pain treatment (Comfortneoscore \>/\= 14\)
  • A minimum of 48 hours persistent pain treatment is required
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • 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

  • No necessity for pain treatment
  • macrosomia (weight at birth \> p 97\)
  • (severe) congenital abnormalities
  • Less than 48 hours pain treatment is required
  • Neonates are sedated or paralysed (Comfortneoscore impossible)
  • severe asphyxia (Apgar score \< 4 after 5 minutes)
  • Hepatic\- and renal failure (at first blood screening)
  • Rectal blood loss
  • Necrotizing enterocolitis (active fase)
  • Severe thrombocytopenia (\< 50 x 10 9/l)

结局指标

主要结局

未指定

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