A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 10
- 主要终点
- Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)
研究概览
简要总结
Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly).
Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.
Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.
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
- None
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birth weight <1000g
- •postnatal age <48 hours
- •no transfusion beyond first 6 hours of life
- •estimated gestational age of 30 completed weeks or less
排除标准
- •infant considered non-viable by attending physician
- •infant has cyanotic congenital heart disease
- •infant's parents known to be opposed to blood transfusion
- •either parent has hemoglobinopathies or congenital anemias
- •infant has hemolytic disease
- •infant has severe acute hemorrhage, severe shock, severe sepsis with coagulopathy or requires peri-operative transfusion
- •prior treatment with or intention to treat with erythropoietin
结局指标
主要结局
Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)
时间窗: neonatal phase
Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)
时间窗: follow-up phase 18 months corrected age
次要结局
- time on oxygen(neonatal phase)
- growth in weight and head circumference(neonatal phase)
- time to extubation(neonatal phase)
- length of hospital stay until discharge home(neonatal phase)
- confirmed necrotizing enterocolitis(neonatal phase)
- apnea requiring treatment(neonatal phase)
- culture-proven infections(neonatal phase)
- use of post-natal steroids(neonatal phase)
- mean levels of hemoglobin(neonatal phase)
- number of transfusions(neonatal phase)
- number of donor exposures(neonatal phase)
- serum ferritin levels(neonatal phase)
- milder forms of cerebral palsy(follow-up phase 18 months corrected age)
- milder neurologic disorder(follow-up phase 18 months corrected age)
- personal and social functional capabilities(follow-up phase 18 months corrected age)
- hydrocephalus requiring a shunt(follow-up phase 18 months corrected age)
- seizure disorder(follow-up phase 18 months corrected age)
- respiratory disease(follow-up phase 18 months corrected age)
- iron nutritional status(follow-up phase 18 months corrected age)
- physical growth including head size(follow-up phase 18 months corrected age)