A Randomised Controlled Intervention, Multi-centre Study Aiming to Preserve Blood Factors Using Micro-methods to Improve Development in Extremely Preterm Infants - "Less is More"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- David Ley
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Broncho-pulmonary dysplasia
研究概览
简要总结
Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine. Excessive blood sampling volumes and the resulting loss of fetal blood components are related to neonatal morbidity. This randomised trial aims to provide evidence that preservation of blood using micro-methods results in decreased morbidity and increased quality of life in extremely preterm infants.
详细描述
Extremely preterm (EPT) infants are subjected to a sample-related withdrawal of whole blood of 50 % of total blood volume during the first 2 postnatal weeks and a transfused volume of 100 % of total blood volume with donor blood during the corresponding time period. The resulting decrease in the proportion of fetal hemoglobin is strongly associated with morbidity outcome, especially broncho-pulmonary dysplasia (BPD), in the EPT infant.
This randomized trial evaluates if a reduction in sample-related blood volume loss by 50% during the first two postnatal weeks leads to a reduced rate of BPD in EPT infants. Half of the included infants will be subjected to clinical blood sampling using micromethods during the first two postnatal weeks whereas blood sampling in the other half of infants will be performed using standard clinical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Prevalence and severity of BPD at 36 weeks post-menstrual age is determined by the oxygen challenge test performed by a trained respiratory nurse blinded to treatment at each study site.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age < 27 weeks at birth
排除标准
- •major malformation
结局指标
主要结局
Broncho-pulmonary dysplasia
时间窗: Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks
Requirement of supplemental oxygen as determined by the oxygen challenge test
次要结局
- Blood transfusions(Blood transfusions administered during the first two postnatal weeks)
- Necrotizing enterocolitis(From birth until 40 weeks postmenstrual age)
- Fetal Hemoglobin(% of fetal hemoglobin at 7 and 14 postnatal days)
- Cerebral intraventricular haemorrhage(Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age)