跳至主要内容
临床试验/NCT04021927
NCT04021927撤回不适用

Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy

University of Minnesota2 个研究点 分布在 1 个国家开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Safety of Reflective Ring PT Device: Number of participants who experience an episode of oxygen desaturation

研究概览

简要总结

This is a descriptive prospective study of safety and efficacy of the reflective PT ring device. Neonates with an elevated total serum bilirubin (TSB) meeting PT criteria per their clinician during hospital admission will be eligible for enrollment after informed parental consent.

详细描述

Neonatal jaundice (NNJ) continues to be a significant global problem affecting over 80% of neonates while severe neonatal jaundice affects at least 481,000 neonates annually. Jaundice and jaundice related complications like Kernicterus Spectrum Disorder (KDS) are gaining recognition among the world's health policy leaders as an important area for further research and development. The long-term sequelae of KSD include choreoathetoid cerebral palsy, sensorineural hearing loss, and upward gaze palsy. KSD is irreversible resulting in a lifetime of physical, emotional, social and economic challenges. Access to cost-effective methods of improving pediatric jaundice care along with improved circumferential (full body) illumination technologies is an affirmed objective of the AAP (American Academy of Pediatrics). The investigators hypothesize that unused therapy light (irradiance) surrounding the neonate using an existing single-lamp bank phototherapy (PT) device is sufficient in quantity and if redirected onto the patients untreated or poorly illuminated skin surfaces, it will accelerate metabolism and excretion of bilirubin. This PT ring device redirects unused phototherapy light sideways onto the neonate body using an open-faced ring approach. The technology will illuminate previously unexposed and poorly exposed skin regions where treatable bilirubin exists. The device is superior to current PT devices in that it converts existing waste light into treatment efficacy while integrating into existing overhead lamp systems offsetting the purchase of secondary devices that are often unaffordable and create hospital complexity, cost and inefficiency issues. A further benefit of the device will be reduced ambient blue-light spillover in patient care areas, an ongoing concern for medical staff.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Males or female neonates greater than or equal to 35 weeks gestational age
  • Elevated total serum bilirubin levels meeting PT criteria in the first 7 days of life

排除标准

  • Neonates, who are mechanically ventilated
  • Neonates requiring continuous positive airway pressure
  • Neonates with a history of apnea, bradycardia
  • Patients with known cyanotic heart disease
  • Patients experiencing temperature instability or desaturation episodes in 24hr prior to enrollment will be excluded.
  • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

结局指标

主要结局

Safety of Reflective Ring PT Device: Number of participants who experience an episode of oxygen desaturation

时间窗: Entirety of hospital admission, approximately 5 days

Number of participants who experience an episode of oxygen desaturation during treatment

Safety of Reflective Ring PT Device: umber of participants who experience fluctuations of body temperature

时间窗: Entirety of hospital admission, approximately 5 days

Number of participants who experience fluctuations of body temperature outside the normal range during treatment

Safety of Reflective Ring PT Device: Number of participants who experience a bradycardic episode

时间窗: Entirety of hospital admission, approximately 5 days

Number of participants who experience a bradycardic episode during treatment

Safety of Reflective Ring PT Device: Number of participants who experience apnea

时间窗: Entirety of hospital admission, approximately 5 days

Number of participants who experience apnea during treatment

次要结局

  • Efficacy: Percent of Participants with Normal Serum Bilirubin Concentrations(Entirety of hospital admission, approximately 5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验