Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Temperature of incubator
研究概览
简要总结
A team of researchers at Rice University and Queen Elizabeth Central Hospital (QECH) are working to develop a low-cost infant incubator called "IncuBaby" that consists of two components: a temperature sensor that can continuously monitor an infant's temperature, and a heated, enclosed area that can adjust internal temperature based on the feedback from the temperature sensor. This robust, low-cost device will allow for the individualized treatment of hypothermia with minimal intervention from the clinical staff. In this study, researchers intend to evaluate the efficacy of this incubator at QECH by comparing infants' temperatures before and after treatment, and calculating the proportion of time that the infants remain in a normothermic range after rewarming. During phase I of this study, the infants will be continuously monitored using the IncuBaby temperature sensor and a gold standard temperature monitor for up to 3 days. The accuracy of the IncuBaby temperature sensor will be determined by calculating the difference between the temperatures recorded by the temperature sensor and the commercial patient monitor at each point in time. During phase II of the study, infants in need of thermal care with an incubator will be treated with an IncuBaby device and their temperatures will be continuously monitored by both the temperature sensor of the IncuBaby device and a commercially available patient monitor. Care will continue at the clinician's discretion until the infant can be weaned from the incubator or until patients are withdrawn from the study and placed on the standard of care. To determine the effectiveness of the IncuBaby device at warming infants, the temperatures of the infants will be compared before and after treatment for each subject. The proportion of time the device maintains the subject's temperature in a normal range will also be calculated.
详细描述
This is a two-phase, pilot prospective study to determine the effectiveness of a low-cost incubator in warming infants and regulating their temperatures. The temperature sensor that controls the heat of the incubator based on the infant's temperature has been previously evaluated in Rice IRB approved studies in Houston, TX with plans to evaluate at QECH. The first phase will validate the use of the temperature sensor in infants by comparing it to a commercial temperature monitor. The second phase will test the effectiveness of the IncuBaby device using that temperature sensor to regulate the heat of the infant.
Treatment and Monitoring of Neonates
During Phase I, the following steps will be taken:
A trained study nurse will assess the subject for clinical complications before attaching the temperature monitoring device.
A trained study nurse or clinician will attach the temperature monitoring device to the infant. A trained research assistant from Rice University or from the Biomedical Engineering Department at Malawi Polytechnic will observe all procedures and will notify the nurse of any observed errors so they may be corrected. They will also be able to answer any technical questions from the nurse.
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 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is currently being treated at QECH in the neonatal ward.
- •An IncuBaby device and study monitor are available for use.
- •The subject's caregiver has provided informed consent for their child to participate (consent form attached to this proposal).
- •Phase II only: the subject is eligible for thermal care in an incubator. If the subject is recommended for KMC, they will not be eligible for participation in this study. To be considered for care with the IncuBaby, infants should be:
- •Less than 1000 g
- •Or > 1000 g but
- •Receiving medical interventions such as CPAP, oxygen, phototherapy, or IV
- •Unstable, critically ill or surgical conditions
- •No mother or caregiver available for KMC
- •Mother too sick to provide KMC
- •Clinician in charge has decided against KMC as requires closer supervision by nursing staff
- •No space in KMC
排除标准
- •The subject may be excluded from the study at the clinician's discretion for any reason including potential for skin irritation, cough or other condition that may preclude use of the temperature belt, or concurrent treatments that may require increased patient care. Only subjects eligible for care in an incubator will be enrolled in phase II.
结局指标
主要结局
Temperature of incubator
时间窗: from time of enrollment until intervention is complete; up to 28 days
Continuously measured temperature of incubator
Temperature of infant
时间窗: from time of enrollment until intervention is complete; up to 28 days
Continuously measured temperature of infant
Temperature monitor accuracy
时间窗: from time of enrollment until intervention is complete; up to 28 days
Continuously measured temperature for temperature monitor compared against Philips Intellivue patient monitor
次要结局
- Time until normothermia(from time of enrollment until intervention is complete; up to 28 days)
- Proportion of time normothermic(from time of enrollment until intervention is complete; up to 28 days)