NCT01852500已完成4 期
Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
European Institute for Evidence Based Osteopathic Medicine2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2010年11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
- 250
- 试验地点
- 2
- 主要终点
- Evaluate the effectiveness of sham OMT in reducing LOS
研究概览
简要总结
Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.
The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.
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
- 是
入选标准
- •preterm infants born at age between 29 and 37 weeks
- •sham osteopathic treatment performed < 14 days after birth
- •preterm infants born in the same hospital
排除标准
- •gestational age < 29, > 37 weeks;
- •sham 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 sham 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
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Effect of Osteopathic Manipulative Treatment on Pain in PretermsPrematurityNCT02146677European Institute for Evidence Based Osteopathic Medicine120
Available
不适用
Osteopathic Approach Into Neonatology Ward: the NE-O ModelThe Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns.NCT01902563European Institute for Evidence Based Osteopathic Medicine
已完成
不适用
Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical TrialPrematurityNCT01645137European Institute for Evidence Based Osteopathic Medicine690
已完成
不适用
Examining the Effectiveness of Cognitive TrainingCognitive ChangeNCT04344028University of Wisconsin, Madison287
已完成
不适用
Back to Basics - Effects, Narratives and Routes of Administration of Open-label PlaceboPlacebo EffectPainExpectancyNCT02578420University Hospital, Basel, Switzerland160