Effect of Osteopathic Manipulative Treatment on Pain in Preterms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- changes from baseline in pain using Premature Infant Pain Profile (PIPP)
研究概览
简要总结
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Moreover it was reported the absence of adverse events and side effects considering the approach safe (Cerritelli 2013, 2014).
OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 26 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants
- •written informed consent by parents or legal guardians
- •preterms born in the same hospital
排除标准
- •Gestational age > 37 weeks
- •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)
结局指标
主要结局
changes from baseline in pain using Premature Infant Pain Profile (PIPP)
时间窗: baseline and end of hospitalization, average length of hospitalization expected 4 weeks
次要结局
- Number of days of length of stay(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)