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临床试验/NCT04534335
NCT04534335已完成不适用

The SSSH's: SNOO Smart Sleeper Use in Post-Operative Infants With Congenital Heart

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Length of time of utilization of SNOO for each infant

研究概览

简要总结

Study Title The SSSH Study: SNOO Smart Sleeper Use in Post-Operative Infants with Congenital Heart Disease is a single site, cross-sectional, feasibility study of an infant smart sleeper. The Primary Objective is to evaluate the feasibility of collecting and integrating clinical data and SNOO data. The secondary Objective(s) is To assess the feasibility of conducting a future broader trial by evaluating the parents willingness to give parental permission for participation in the use of the SNOO. Research Intervention(s)/ Investigational Agent(s) SNOO Smart Sleeper from Happiest Baby, Inc.There are approximately 300 new infants per year who undergo cardiac surgery at Children's Mercy Kansas City (CMKC) who are 6 months of age and 11kg or less at the time of surgery Sample Size. A maximum of 15 patients will be enrolled for this feasibility study over the study Duration for Individual Participant Length of hospitalization on 4Sutherland, average length of stay for this patient population is 30 days.

详细描述

Infants with congenital heart disease (CHD) are a low frequency but high acuity and stress population in the pediatric hospital setting. There are approximately 300 patients admitted a year that require cardiac surgery and are under the age of 6 months at Children's Mercy. These patients may spend less time in the hospital, but the care they require is often complex resulting in potential hemodynamic changes and pain responses for the infants. Smart technologies are used in CHD populations like single ventricle interstage monitoring at home, CHAMP App, but there are opportunities for baby-parent-nurse in-hospital smart solutions such as the SNOO Smart Sleeper bassinet by Happiest Baby INC . The SNOO Smart Sleeper has been used in more than 20 other hospitals across the country, including The University of Kansas Health System, mainly for infants related to preterm or neonatal abstinence syndrome (NAS). The SNOO utilizes some of the components of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) to aid as physical interventions for infant pain. This has been shown to be effective for pain reduction and less crying time after painful procedures . The calming response for infants has been seen to improve with soothing of the infant through supine mechanical movement, swaddling, and sound . A prospective observational cohort of preterm (32-36 weeks GA) neonates found that intermittent hypoxia and bradycardia significantly declined after use of womb-like soothing sound. The auditory neural pathways have close anatomical connection to the autonomic nervous system and the potential for auditory to parasympathetic response and reduced cardiac and respiratory rates are intriguing for evaluation in the infant population after cardiac surgery. The SNOO has yet to be used in the post-operative pediatric CHD population in the inpatient setting. The success in other fragile infant populations lends to a possible new area for use in the high risk CHD population in the post-operative recovery phase related to pain and hemodynamic changes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •infants who have recently undergone cardiac surgery or cardiac catheterization for a stent for pulmonary blood flow at Children's Mercy Kansas City
  • •less than or equal to 6 months of age and under 11kg .

排除标准

  • •Greater than 6 months of age or over 11kg

结局指标

主要结局

Length of time of utilization of SNOO for each infant

时间窗: 6 months

Feasibility of new device for use in the pediatric cardiac surgery infant population

次要结局

  • Number of parents receptive to use of the SNOO(6 months)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Erickson

Director, Remote Health Solutions, PhD

Children's Mercy Hospital Kansas City

研究点 (1)

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