Preclinical studies to investigate citrate- functionalized Tri-Manganese Tetraoxide Nanoparticles for its Bilirubin reduction properties for risk of severe neonatal hyperbilirubinemia.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes. If TSB level after 6hrs (avg time to arrange the blood for blood exchange is 6hrs in our institute) stays beyond exchange level, exchange will be done.
研究概览
简要总结
Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes.
Study: Prospective, ethical and compassionate trial (n=40), Eligibility: TSB @ escalated level, Follow up: 5 years.
Study: Adjunctive impact: RCT: placebo, blind (n=80 each arm); Eligibility: TSB at (or <1 mg below Photo Therapy level Follow up: 5 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes.
排除标准
- •Infants whose parents refused to provide informed consent Infants with conjugated hyperbilirubinemia Infants with other threatening congenital anomalies.
结局指标
主要结局
Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes. If TSB level after 6hrs (avg time to arrange the blood for blood exchange is 6hrs in our institute) stays beyond exchange level, exchange will be done.
时间窗: 0,2,6,12,24,48 hrs
For Phototherapy group. Duration of PT will be noted for both groups.
时间窗: 0,2,6,12,24,48 hrs
次要结局
- To observe the neurodevelopmental outcomes along with hearing assessment at 8days, 1 month, 3 months, 6months & 1 year. BERA at 3 months, HINE from 3(months onwards, MRI Brain at 6 months besides clinical outcome & nutritional)
研究者
Dr Asim Kumar Mallick
Nil Ratan Sircar Medical College and Hospital