To evaluate the safety and effectiveness of packed red blood cell transfusions in two different doses in very low birth weight babies in neonatal intensive care unit.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- • The primary outcome will be post transfusion change in haemoglobin and hematocrit in infants following both PRBC transfusion treatment sequences.
研究概览
简要总结
Background: Blood transfusion is one of the lifesaving modalities in low birth weight babies. The very low birth weight babies (VLBW) are the most common recipient of multiple blood transfusion units due to their immaturity and illness and they are more vulnerable to adverse effects because of physiological immaturity of organ system. The doses generally used for PRBC is 20 ml/kg as a single aliquot which s well tolerated. The doses of 10 ml/kg in two different aliquots also practised and equally effective but tolerability varies. .
Objectives: To evaluate the safety and effectiveness of 20 mL/kg single aliquot vs 10 ml/kg of 2 aliquots of packed red cell transfusions in very low birth weight babies.
Study design: This will be a randomized double blind control trial and will be conducted in 20 bedded NICU in AVBRH hospital,Sawangi Meghe rural Hospital, Maharashtra. The total sample size is 104 and duration is 18 months. The inclusion and exclusion criteria’s has been defined and patients will be recruited as per the criteria.
Methodology and data analysis: Informed parental consent will be obtained for eligible patients and then each infant will be randomized, using a random number generator as decided by the computerised slip, to one of the two treatment sequences: one receiving 20 mL/kg transfusion and other 10 mL/kg , 2 aliquots , 24 hours apart. Vital signs will be monitored hourly during and up to 6 hours after transfusion. Haematocrit, haemoglobin, and red blood cell counts will also collected 1 hour before transfusion and for 3 hours after transfusion.The data’s will be entered in spread excel sheet. Mean and range of haemoglobin, haematocrit and other parameters will be calculated and compared between two methods. Mean in 2 groups will be calculated and compared using chi square test. P values will be calculated and P value >0.5 will be taken as significant.
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 30.00 Day(s)（—）
- 性别
- All
入选标准
- •All babies requring PRC transfusion weighing less than 1500 gram.
- •All preterm and IUGR babies needing PRC transfusion in NICU Babies receiving PRC for any of the reasons.
排除标准
- •Babies with birth weight more than 1500 gm and less than 500 gram.
- •Major congenital anomalies and Congenital heart defects
- •Patient undergone exchange transfusion.
结局指标
主要结局
• The primary outcome will be post transfusion change in haemoglobin and hematocrit in infants following both PRBC transfusion treatment sequences.
时间窗: • Subject enrollment at the time of admission. | Administration of PBRC : 0 day | PRBC tolerance : 2 days | primary Outcome : 1 week | Tolerance and recovery: 4 week | Data collection: 4-8 months | analysis: 10 th month | Declaration of result: 12 month
• The total stay in the hospital and outcome in form of death.
时间窗: • Subject enrollment at the time of admission. | Administration of PBRC : 0 day | PRBC tolerance : 2 days | primary Outcome : 1 week | Tolerance and recovery: 4 week | Data collection: 4-8 months | analysis: 10 th month | Declaration of result: 12 month
次要结局
- number of stay of days(Number f patients developed NEC)
研究者
Dr Mahaveer Singh Lakra
JNMC,Datta Meghe Institute of higher education and Research, Sawangi Meghe, Wardha,Maharashtra