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临床试验/NCT01544257
NCT01544257已完成4 期

Effect of OMT on Length of Stay in a Population of Preterm Infants: RCT Study

European Institute for Evidence Based Osteopathic Medicine2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
evaluate the effectiveness of OMT in reducing LOS

研究概览

简要总结

The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of premature infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
29 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • preterm infants born at age between 29 and 37 weeks
  • osteopathic treatment performed < 14 days after birth
  • preterms born in the same hospital

排除标准

  • gestational age < 29, > 37 weeks;
  • osteopathic treatment performed > 14 days after birth;
  • newborn transferred to/from other hospital;
  • newborn from to HIV seropositive and/or drug addict mother;
  • newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

结局指标

主要结局

evaluate the effectiveness of OMT in reducing LOS

时间窗: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

次要结局

  • pre-post difference in weight gain(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)

研究者

发起方
European Institute for Evidence Based Osteopathic Medicine
申办方类型
Other
责任方
Sponsor

研究点 (2)

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