Newborn Abdominal Massage to Prevent Hyperbilirubinemia: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acceptability of the newborn massage intervention
研究概览
简要总结
The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Hours 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn admitted to the well newborn/postpartum care unit at UC Davis Medical Center
- •Less than 48 hours of age at enrollment
排除标准
- •Infant has already received phototherapy
- •Mother/birthing person is incarcerated
- •Infant unexpected to discharge into parental care
- •Parental inability to speak or read in English
- •Infant without parent rooming-in with them in the hospital
结局指标
主要结局
Acceptability of the newborn massage intervention
时间窗: Through study completion, up to one year
Acceptability of the intervention will be defined by the 1-sided 95% confidence interval for the proportion of the intervention group performing massage at least once to include 80% and for the 1-sided 95% confidence interval for at the proportion performing massage as directed to include 70%.
Feasibility of recruitment
时间窗: Ascertained following completion of recruitment of 30 study participants. Through study completion, up to an average of one year.
Feasibility of recruitment will be defined by at least 30% of approached, eligible participants consenting to participate.
次要结局
- Proportion of participants who read with baby in the last week(1-2 week survey)
- Timing of first transitional (non-meconium) stool passage(Ascertained at 1-2 week survey)
- Parental satisfaction with newborn massage(7-14 day survey)
- Proportion of participants who read with baby in the last 24 hours(1-2 week survey)
- Difference between transcutaneous bilirubin level and AAP phototherapy threshold on the day of discharge(Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year)
- Number of stools in prior 24 hours (at hospital discharge)(Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year)
- Breastfeeding at 1 week of age(1-2 week survey)