Field Evaluation of a Point-Of-Care Test for Serum Bilirubin Levels in Infants Born in a Tropical Limited-resource Setting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons
研究概览
简要总结
This is an observational prospective study. The main purpose is to evaluate the stability of the Bilistick system in a humid and hot climate compared to the quantitative test for serum bilirubin (SBR) measurement currently used, the BR-501 total bilirubin meter, kept in a controlled environment.
The secondary aim is to assess the operational feasibility of the Bilistick system in a tropical limited-resource setting, when used by locally trained nurses.
详细描述
Study procedure:
- SBR will be measured in parallel with two tests during three distinct seasons. (Cold, hot, rainy). The Blood is from an extra capillary sample taken from a single heel prick done for routine SBR) BR-501 total bilirubin meter, the quantitative test for SBR currently used, will be kept in a controlled environment while the new bilirubin test (Bilistick system) will be exposed to tropical conditions.
- Trained nurses will use the Bilistick system observed by a qualified laboratory technician; Usability of the Bilistick system by the trained nurses will be evaluated via a 5-point Likert scale questionnaire and focus groups discussions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written or thumb print for informed consent from the parent
- •Infant born ≥ 35 weeks of gestational age
- •Infant who needs a routine SBR measurement
- •Infant in stable clinical condition prior to SBR measurement confirmed by the trained nurses
排除标准
- •The participant will not be enrolled in the study if ANY of the following applies:
- •Infant who already had 1 SBR measurement done with the Bilistick system
- •Last haematocrit measurement > 65% or no previous haematocrit measurement
结局指标
主要结局
Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons
时间窗: 18 months
The main outcome of interest is the potential effect of environmental conditions on the quantitative outcome of the Bilistick System, using BR-501 bilirubin meter machine as a reference. The Bland-Altman analysis will be used to compare the two tests.
Within each season, evaluation of the impact of temporal variation on the agreement of serum bilirubin measurement between the two tests.
时间窗: 18 months
A linear regression analysis will be done to look for statistically significant effect of exposure time on the difference between the average total bilirubin serum levels of the two tests.
次要结局
- Evaluation of the usability of the Bilistick system using a 5-point likert scale questionnaire and a focus group discussions(18 months)
- Perception by the trained nurses of the Bilistick system usability with a focus group discussion (FGD).(18 months)