Calmer: A Novel Approach for Treating Infant Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Behavioral Indicators of Infant Pain (BIIP) Score
研究概览
简要总结
The purpose of this study is to see if the Calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit.
Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain scores and lower heart rates, and more stable autonomic regulation as measured by heart rate variability indices, than infants given a soother plus facilitated tucking (standard of care) during routine blood collection.
详细描述
60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 27 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable infants admitted to the Neonatal Intensive Care Unit at Children's and Women's Health Centre of British Columbia (C&W)
- •Preterm infants born at 27 to 36+6 completed weeks gestational age (GA) will be included
- •GA is determined on the basis of the first day of the last menstrual period, early gestation ultrasonogram (in most cases) or best estimate based on neonatal examination
- •Mothers must speak enough English to provide consent
排除标准
- •Infants who have congenital anomalies, active, ongoing infection, or have undergone surgery
- •Infants who have received pharmacological analgesics or sedatives within 72 hours of the assessment
- •History of maternal abuse of controlled drugs and substances; blood collection that occurs beyond the 35th completed week (35 weeks + 6 days) GA
- •Small for GA defined as a birth weight at least 2 standard deviations below mean for GA
- •Higher order multiples (e.g. triplets)
- •Infants in a cot
研究组 & 干预措施
Calmer
This therapeutic platform, called the Calmer interacts with the infant to help reduce stress to help promote better outcomes. It is being tested to see if it mimics Kangaroo care, maternal skin to skin, to help promote better health outcomes. Infants would be placed on it prior, during and after bloodwork to see if it elicits a favorable response.
干预措施: The Calmer (Device)
Standard Care
Standard of care during bloodwork is receiving a soother and facilitated tucking.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in Behavioral Indicators of Infant Pain (BIIP) Score
时间窗: During the assessment period in the study, estimated to occur around one hour.
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
次要结局
- Secondary Outcome Measures: Heart Rate Variability(During and after assessment period in the study, estimated to be 6 hours.)
- Secondary Outcome Measures: NIRS(During the assessment period in the study, estimated to occur over less than an hour.)
- Secondary Outcome Measures: Heart Rate(During and after the assessment period in the study, estimated to be 6 hours.)
研究者
Liisa Holsti
Associate Professor
Children's & Women's Health Centre of British Columbia