Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 690
- 试验地点
- 6
- 主要终点
- Number of days of LOS
研究概览
简要总结
The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).
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
- •osteopathic treatment performed < 14 days after birth
- •preterms born in the same hospital
排除标准
- •Gestational age < 29 weeks
- •Gestational age > 37 weeks
- •First OMT performed after 14 days from birth
- •genetic disorders
- •congenital disorders
- •cardiovascular abnormalities
- •proven or suspected necrotized enterocolitis with or without gastrointestinal perforation
- •proven or suspected abdominal obstruction
- •pre/post surgery patients
- •pneumoperitoneum
- •atelectasis
- •Newborn from an HIV seropositive/drug addicted mother
- •respiratory disorders
- •transferred to/from other hospital
- •admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)
研究组 & 干预措施
OMT
patients under usual medical care plus osteopathic treatment
干预措施: osteopathic manipulative treatment (Other)
control
patients under usual medical care
干预措施: Usual care (Other)
结局指标
主要结局
Number of days of 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)
- number of episodes of vomit(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- days to full enteral feeding(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- NICU costs(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- number of episodes of regurgitation(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- number of episodes of stooling(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)