Hand-held mobile based device for non-invasive Bilirubin monitoring in neonates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Real-time estimation of bilirubin in neonates using multi-spectral and digital image data obtained from the hand-held device.
研究概览
简要总结
In the proposed research, we intend to develop and test a non-invasive transcutaneous bilirubinometer for neonates. The proposed device addresses the concerns and gaps in technology in a developing country like India namely:
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Low-cost
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Simple operational procedure that doesn’t not need trained professionals
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Dual-detection technology for better reliability
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Multi-sampling method for enhanced accuracy
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Automated internal calibration without the requirement of manual calibration
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Instant data transfer to the mobile-phone
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Zero maintenance charge (excl. electricity for charging)
The device will replace the capital intensive imported equipment in healthcare centers and present a novel and unique ‘MAKE IN INDIA’ product.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 21.00 Day(s)（—）
- 性别
- All
入选标准
- •All neonates between 0 to 3 weeks of life presenting to the Sri Sathya Sai General Hospital with clinically visible jaundice will be part of this study.
排除标准
- •Neonates who have received phototherapy, without the skin patch.
- •Where skin condition does not permit, such as Ichthyosis and Hydrops.
结局指标
主要结局
Real-time estimation of bilirubin in neonates using multi-spectral and digital image data obtained from the hand-held device.
时间窗: Sampling every 12 hours. In addition to this, the study will incorporate screening for bilirubin in neonates delivered at SSSGH at 72 hours of life as a part of the unit’s standard operating procedure. The hour specific Bhutani nomogram will be used to guide subsequent follow-up.
次要结局
- Facilitate the early diagnosis and management(of jaundice in neonates)