A Randomized Controlled Trial Comparing Phototherapy with Single or Double or Portable Modes Versus Conventional Phototherapy in Neonates with Non Hemolytic Unconjugated Hyperbilirubinemia in a Tertiary Care Hospital
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 268
- 试验地点
- 1
研究概览
简要总结
This study is a prospective single center open label randomized controlled trial which will be conducted to evaluate the safety efficacy and usability of the nLite360 phototherapy device compared with conventional Light Emitting Diode phototherapy in neonates greater than equal to35 weeks gestation with non hemolytic unconjugated hyperbilirubinemia. A total of 268 eligible neonates will be randomized in a 1:1 ratio using block randomization with allocation concealment The intervention group will receive phototherapy using nLite360 single double high intensity or portable modes while the control group will receive centers standard phototherapy The primary outcome is the rate of total serum bilirubin decline mg/dL/hour and over 24 hours Secondary outcomes include temperature instability assessment of side effects hospital stay maternal and staff usability assessment using a validated Likert scale exchange transfusion and phototherapy duration requirement. Statistical analysis will follow an intention to treat approach The trial aims to generate clinical evidence to support regulatory validation and clinical adoption of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Month(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Gestational age greater than equal to thirty five weeks b.
- •Unconjugated hyperbilirubinemia requiring phototherapy as outlined by American Academy of Peadiatrics guidelines 2022.
排除标准
- •Isoimmunization, kernicterus, or conjugated hyperbilirubinemia b.
- •Congenital anomalies or other major co-morbidities c.
- •Ventilator support or hydrops fetalis d.
- •Hemolytic neonates as indicated by reticulocyte count and anemia for age.
研究者
Dr Prashanth Thankachan
St. Johns Research Institute