Understanding Neonatal Jaundice in Rwanda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Length of hospital duration for infant jaundice
研究概览
简要总结
This study exploits the distribution of low-cost high-quality phototherapy devices (Brilliance by D-Rev) to public hospitals in Rwanda to assess whether the provision of improved technology improves health care for infant jaundice. Specifically, the investigators are interested in measuring whether the provision of an additional high-quality phototherapy device, a known effective treatment for jaundice, successfully translates into improved care of neonatal jaundice in Rwanda where the burden of jaundice is particularly high.
详细描述
The Ministry of Health (MIH) in Rwanda has planned to provide Brilliance devices (phototherapy) to 46 public hospitals in Rwanda. The investigators have worked with MIH to have the delivery of these machines be staggered over three phases through random selection. The methodology relies on the staggered distribution of Brilliance devices and survey data collected prior and during delivery dates to evaluate the provision of low-cost high quality phototherapy machines, following the basic design of a staggered randomized controlled trial. Specifically, the investigators will survey all hospitals prior to the receipt of any Brilliance devices to provide a baseline description of the care received in these facilities. These surveys will collect information on the facility itself, including average infant jaundice caseloads and descriptions of recent cases. The investigators will then randomly select 15 hospitals to receive the Brilliance units. Three months after installation of Brilliance has occurred at these facilities (Group 1), another randomly selected subset of 16 facilities (Group 2) will receive their Brilliance machines. Three months after these installations have been completed, the remaining facilities (Group 3) will receive their Brilliance machines. During this period, there will be ongoing data collection from the hospitals, creating a panel dataset on the jaundice-related caseloads at these facilities. The data collected will be akin to collecting hospital records of patients diagnosed with jaundice, but no identifiable patient information will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patient level record (de-identified), diagnosed by the facility for having infant jaundice
- •The facilities are included based on selection by the Ministry of Health for receiving additional phototherapy machines.
排除标准
- 未提供
研究组 & 干预措施
Phase 3
This is the last set of hospitals to receive the device. For the first six months, they receive no intervention, after which the study is completed and they are given the device Brilliance.
*No individual participants are recruited for this study.
Phase 1
This is the first set of randomly selected hospitals to receive the intervention (Brilliance device). The intervention to be provided is the phototherapy device, Brilliance.
*No individual participants are recruited for this study.
干预措施: Brilliance (Device)
Phase 2
This is the second set of hospitals to receive the device. For the first three months, they receive no intervention, after which they become part of the "active comparator" arm. The intervention to be provided is the phototherapy device, Brilliance.
*No individual participants are recruited for this study.
干预措施: Brilliance (Device)
结局指标
主要结局
Length of hospital duration for infant jaundice
时间窗: Through study completion, an average of 9 months
This is measured by the duration of stay at the facility, as measured by the time between being admitted and being discharged. The analysis is conditional on the subset of infants diagnosed with jaundice.
Length of treatment for infant jaundice
时间窗: Through study completion, an average of 9 months
Number of hours infant diagnosed with jaundice is provided phototherapy (PT). This is calculated by subtracting the age at which the patient is first given PT from the age at which the patient is removed from PT. The analysis is conditional on the subset of infants diagnosed with jaundice.
次要结局
- Improved Treatment of Jaundice by Reducing Exchange Transfusions(Through study completion, an average of 9 months)
- Improved Treatment of Jaundice by Receiving Phototherapy(Through study completion, an average of 9 months)
- Improved Treatment of Jaundice by Using Single Phototherapy Device(Through study completion, an average of 9 months)
- Increased rate of reduction in bilirubin(Through study completion, an average of 9 months)
- Improved Treatment of Jaundice(Through study completion, an average of 9 months)
- Improved Treatment of Jaundice By Not Being Referred Elsewhere(Through study completion, an average of 9 months)
- Improved Treatment of Jaundice by Not Sharing Phototherapy(Through study completion, an average of 9 months)
- Improved Treatment of Jaundice by Not Meeting Threshold for Exchange Transfusion(Through study completion, an average of 9 months)
研究者
Ketki Sheth
Assistant Professor
University of California, Merced
