Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Average daily duration of SSC
研究概览
简要总结
The purpose of this study is to assess the impact of the Skincubator on average daily duration of Skin-to-skin Care (SSC), to assess the safety of Skincubator-supported SSC during NICU hospitalization, to evaluate feasibility and acceptability of the Skincubator among parents and clinical staff using the Acceptability of Intervention Measure (AIM) implementation framework to assess thermal stability during Skincubator-supported SSC and to assess changes in parental stress associated with Skincubator use during NICU hospitalization.
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
- None
入排标准
- 年龄范围
- — 至 6 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extremely preterm (EP) and preterm (PT) infants born between 24 0/7 and 30 6/7 weeks' gestational age (GA)
排除标准
- •Birth weight > 2kg.
- •Hemodynamic instability, defined as new or escalating inotropic support within 12 hours prior to randomization
- •Chest tube in place at time of enrollment.
- •Oxygenation failure, defined as persistent preductal oxygen saturation < 85% despite 100% fraction of inspired oxygen (FiO2).
- •Recurrent apnea, requiring bag-mask ventilation more than twice within the 12 hours prior to randomization
- •Known or suspected congenital anomalies or genetic conditions, including Trisomy 13, 18, 21 or cystic fibrosis Multiple gestation, including twins or higher-order multiples
- •Determination by the attending neonatologist that participation is not safe for a given infant
研究组 & 干预措施
Skincubator-supported SSC
干预措施: Skincubator-supported SSC (Device)
Traditional SSC (t-SSC)
干预措施: t-SSC (Other)
结局指标
主要结局
Average daily duration of SSC
时间窗: First 7 days following randomization
this will be recorded as mean hours/day
次要结局
- Safety as assessed by the incidence of predefined adverse events(AEs)(From randomization through NICU discharge (upto 100 days from randomization))
- Safety as assessed by the number of infants that experience adverse events(From randomization through NICU discharge (upto 100 days from randomization))
- Safety as assessed by the propotion of infants that experience adverse events(From randomization through NICU discharge (upto 100 days from randomization))
- Feasibility of Skincubator-supported SSC as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff(end of intervention (7 days after randomization))
- Acceptability as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff.(end of intervention (7 days after randomization))
- Thermal Stability as assessed by the percentage of SSC session time(During SSC sessions in first 7 days post randomization)
- Change in parental stress as assessed by the Parental Stressor Scale:NICU (PSS:NICU) score(Baseline, days 5-7 post-randomization)
研究者
Jaclyn Ruggiero
Associate Professor
The University of Texas Health Science Center, Houston