Comparison of reconstituted blood with 40 ± 5% versus 60 ± 5% hematocrit for double volume exchange transfusion in neonates with hemolytic disease of the newborn: a randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the duration of phototherapy in neonates requiring DVET with reconstituted Blood of lower haematocrit (40 ± 5%) in comparison to that with a higher haematocrit (60 ± 5%)
研究概览
简要总结
All neonates with Rh isoimmunization will be screened for enrolment. The parents will be approached for consent after applying the inclusion and exclusion criteria. If consented, the resident on duty will pick a sealed envelope with an allocation of (40±5%) or (60±5%) haematocrit for exchange transfusion. Venepuncture samples will be taken for total serum bilirubin estimation before and after double volume exchange transfusion to monitor and decide on the duration of phototherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All live neonates with diagnosed Rh isoimmunization and requiring DVET will be eligible for the study.
排除标准
- •Major malformations.
结局指标
主要结局
To determine the duration of phototherapy in neonates requiring DVET with reconstituted Blood of lower haematocrit (40 ± 5%) in comparison to that with a higher haematocrit (60 ± 5%)
时间窗: 28 days of life (After DVET till discharge from hospital)which is the neonatal period
次要结局
- To determine the post-exchange serum bilirubin in the two groups at 0, 6 & 12 hours(At 0, 6, & 12 hours after completion of DVET)
- To compare the number of DVET per neonate between the two groups(Till discharge after birth admission)
- To compare the number of packed cell transfusions post DVET between the two groups till 12 weeks(Till 12 weeks of postnatal age)
- To compare the duration of hospital stay between the two groups(Birth to discharge after birth admission)
研究者
Rudresh Naik M R
AIl India Institute of Medical Sciences, New Delhi