Testing A Visual Thermometer in Newborns and Young Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Accuracy of the liquid crystal thermometer with measuring a temperature
研究概览
简要总结
"Severe neonatal jaundice and acute bilirubin encephalopathy are a major cause of death and disability among newborns in LMICs. Filtered sunlight phototherapy (FSPT) was developed, tested and shown to be safe and efficacious in the treatment of jaundice, because effective electric-powered conventional phototherapy is often unavailable10,11. However, FSPT currently requires at least hourly temperature monitoring by healthcare providers (HCPs) because infants receiving FSPT are prone to both hypothermia and hyperthermia.
20 years ago, a liquid crystal thermometer, ThermospotTM (Maternova, Providence, RI) was developed primarily for use in LMICs. It was designed to detect hypothermia and is most sensitive in cold infants and not as sensitive as needed for detecting hyperthermia or fever. The purpose of this pilot study is to determine the accuracy and useability of this LCTD for a wider spectrum of temperatures when used in a large group of infants in a high-income country. If the device performs well in this study, we plan to study it in a low- and middle-income country in Africa."
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants 0-6 months (<7 months) presenting to Masonic Emergency Room or inpatient ward, their parent or caregiver who provide verbal consent in English or through a medical interpreter.
排除标准
- •Any infant undergoing active resuscitation
- •any infant for whom physician deems study enrollment would interfere with their care
- •any infant whose parents or caregiver decline enrollment
- •any nurse or other healthcare provider who declines participation
- •Parents who do not understand English, and do not have a medical interpreter at the bedside.
结局指标
主要结局
Accuracy of the liquid crystal thermometer with measuring a temperature
时间窗: baseline
determining the accuracy of the LCTD in estimating the temperature of infants 0-6 months presenting to the emergency room for treatment
Parents/Caregivers and Healthcare provider accuracy in evaluating the infant temperature
时间窗: baseline
Our secondary endpoint is determining parents/caregivers and healthcare provider accuracy in evaluating the temperature of their infant or the infant they are caring for and determining the category of the temperature.
次要结局
未报告次要终点