Age of Red Blood Cells in Premature Infants Study (ARIPI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 377
- 试验地点
- 2
- 主要终点
- 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
研究概览
简要总结
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birthweight of less than 1250g
- •admitted to participating NICU
- •consent acquired from proxy for the patient
排除标准
- •already received one or more transfusions
- •requirement for an exchange transfusion
- •will be receiving directed donations
- •have rare blood types/difficult cross-match
- •proxy has refused consent
- •moribund on admission to NICU/expected to die
- •mitigating child protection issues
研究组 & 干预措施
Biological
PRBCs that are less than 7 days old are considered 'fresh'.
干预措施: Transfusion (Biological)
Standard PRBCs
PRBCs 'stored' as per hospital policy.
干预措施: Transfusion (Biological)
结局指标
主要结局
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
时间窗: 2 weeks, 4 weeks, 12 weeks, 90 days
The primary outcome was a composite outcome composed of mortality and major neonatal morbidities associated with acute organ dysfunction or failure. In addition to death, the 4 major morbidities comprising the composite outcome were bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage.
次要结局
- Number of Participants Using Mechanical Ventilation.(whether a mechanical ventilation was used at any time point during 90 days)
- Clinically Suspected Infection and Culturally Confirmed Infections(90 days)
- Length of Stay(until last participants left neonatal intensive care unit)