The Effect of Chest-to-Back Skin-to-Skin Contact on Regulation of Physiological Parameters for Low Birth Weight and/or Premature Infants: a Crossover Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in skin temperature from baseline
研究概览
简要总结
The purpose of this study was to assess the effectiveness of Kangarooing small babies on the back of a mother
详细描述
After the study was explained (risks and benefits) and written informed consent was received from participants, an individually controlled randomized crossover clinical trial was conducted to examine the effectiveness of Chest-to-Back (CB) skin-to-skin contact (SSC) compared with the standard. The trial was done in accordance with the protocol, good clinical practice, and the national regulatory and ethics guideline of Ethiopia (which is in line with the Helsinki declaration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Mothers were masked only for the presence or absence of a sequence in the trial. Hospital staffs, students, and investigators of the study were all blinded to allocation of the intervention. Until the study was finalized, access to the database was restricted to the data manager only
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with LBW (<2500 grams)
- •Born prematurely (< 37 complete weeks of gestation)
排除标准
- •less than 35 weeks of gestation on the day of enrollment to trial
- •Malformations or birth disabilities
- •Dependent on oxygen or IV fluid
- •Any disorder that was deemed necessary for exclusion by the investigator.
结局指标
主要结局
Change in skin temperature from baseline
时间窗: : From the start of SSC (0 hour) to end of SSC (2 hours) per day, assessed for three consecutive days
Skin temperature values were recorded every 10 minutes. Including the baseline, the 2 hours intervention would provide 13 measurements. A participant who successfully completed the intervention would have78 measurements; 39 for the treatment arm and 39 for the control arm.
次要结局
未报告次要终点
研究者
SISAY GERE
MSc, PhD candidate, and lecturer at Arsi University College of Health Sciences, Ethiopia
Addis Continental Institute of Public Health