Effects of Acupuncture in the Treatment of Infant Colic: A Prospective Multi-center Single Blinded Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Crying Time Per 24 Hour Period.
研究概览
简要总结
Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture.
The investigators plan to study whether the perceived opinion on positive results can be verified in a multi-center clinical trial. The investigators aim to measure the effect of standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized singe blinded prospective multi-center study, starting September 2009. The study will be done in thirteen locations in Norway by specialists in General Practice trained in acupuncture.
The investigators intend to include a total of 130 patients, 65 in the intervention group and 65 in the control group.
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
- Single (Participant)
入排标准
- 年龄范围
- 3 Weeks 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants under 3 months of age with birth weight over 2500 g and/or over 36th week of gestation.
- •Further fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying per day for more than 3 days a week for more than 3 weeks."
排除标准
- •Infants over 3 months of age with birth weight under 2500 g and/or under 36th week of gestation.
- •Not fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying pr.day for more than 3 days a week for more than 3 weeks."
结局指标
主要结局
Change in Crying Time Per 24 Hour Period.
时间窗: 6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.
Crying time per 24 hour period at baseline and post treatment
次要结局
- Parents Evaluation of Benefit to the Child.(5 days, 1 , and 4 weeks after the first treatment)
研究者
Arne Fetveit
Associate Professor
University of Oslo