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临床试验/CTRI/2024/09/073586
CTRI/2024/09/073586尚未招募不适用

Use of Erythropoetin in reducing blood tranfusion in Extremely Low Birth Weight neonates: A Prospective Observational study

Seth GS Medical College and KEM Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
need for more than 1 blood transfusion in

研究概览

简要总结

Extremely low-birth-weight neonates (ELBW <1 Kg) comprise less than 1% of all births. Their survival rate varies between 11% to 67% in India.This increase in survival has led to an increase in blood transfusions (BT) with up to 70% requiring more than one BT. These blood transfusions increase the risk of necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP). In ELBW infants, hemoglobin falls to levels below 7.0 to 10.0 g/dL by four to 6 weeks of life and is called ’anemia of prematurity’ (AOP), which increases the need for BT. Erythropoietin (EPO) is a glycoprotein hormone, produced by the peritubular cells of the kidney, that stimulates RBC production and plays a vital role in the pathogenesis of AOP. Low EPO levels in ELBW neonates thus provide a rationale for its use in the prevention and treatment of AOP. The Cochrane review comprised of 27 studies with 2209 infants have extensively studied the role of erythropoietin in the prevention of AOP and have concluded that early erythropoietin (< 7 days) reduced the risk of the ’use of one or more BT (typical risk ratio (RR) 0.79, 95% confidence interval (CI) 0.73 to 0.85). Further comparison of early vs late EPO and low dose ( <500 units/kg/week) vs high dose EPO (>500 units/kg/week) was analysed in the Cochrane review (6,7) and showed that the use of early and high dose EPO did not significantly reduce the ’use of one or more BT or the ’number of BT per infant" compared with late or low dose EPO administration. Most of these trials which contributed to Cochrane review were conducted in high and middle-income trials and they had non-uniformity in BT practice.  A prospective observational study from Indian sub-continent has used late and high dose EPO (600 IU weekly till discharge) and found reduction in blood transfusion rate in ELBW infants (9). There is lacunae in literature from the Indian subcontinent about the effectiveness of early and high dose EPO. Hence, we plan to conduct this study to assess the effect of erythropoietin in the prevention of >1 blood transfusion in ELBWs infant and study its effect on short term outcomes of the preterm neonate. 

We hypothesise that the use of EPO in ELBW babies will lead to a decrease in the need of blood transfusion.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Preterm infants less than 28 weeks of gestation and/or & birth weight less than 1000 gms.

排除标准

  • Any known hematological disorders and hemoglobinopathies Hydrops fetalis Critical Congenital Heart Disease Life threatening gross congenital anomalies Any intrauterine transfusion.

结局指标

主要结局

need for more than 1 blood transfusion in

时间窗: 60days

extremely low birth weight infants.

时间窗: 60days

次要结局

  • The total volume (mL/kg or mL/kg/day) of RBCs transfused per infant.(60 days)
  • Number of Blood transfusion per infant.(60 days)
  • Mortality during initial hospital stay (all causes).(28 days)
  • Retinopathy of prematurity (ROP) (any stage and stage 3 or more)
  • Proven sepsis (clinical symptoms and signs of sepsis and positive blood(culture for bacteria or fungi).)
  • Necrotizing enterocolitis(28 days)
  • Intraventricular haemorrhage all grades(28 days)
  • Periventricular leukomalacia(60 days)
  • Length of hospital stay(60 days)
  • Bronchopulmonary dysplasia(60 days)

研究者

发起方
Seth GS Medical College and KEM Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Anitha Ananthan

Seth GS Medical College and KEM Hospital

研究点 (1)

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