Safety, Feasibility and Efficacy of Red Blood Cells From Umbilical Cord Blood for Transfusion of Extremely Preterm Infants: Clinical Phase
概览
- 阶段
- 不适用
- 干预措施
- Red blood cell from umbilical cord blood
- 疾病 / 适应症
- Infant, Extremely Premature
- 发起方
- Hospital Clinic of Barcelona
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Number of participants with abnormal vital signs after UCB-RBC transfusion
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
This study has been designed to demonstrate that red blood cell from umbilical cord blood (UCB-RBC) is a safe and available product for extremely preterm infants (EPI) transfusion and that transfusion of UCB-RBC is non-less effective than RBC from adult donor for the treatment of anemia of prematurity in this group of patients.
详细描述
Prematurity is an important maternal and child health problem due to its incidence and associated complications. Anaemia is a frequent problem in extremely preterm infants (EPI) whose treatment often requires red blood cell (RBC) transfusion. This product is currently obtained from adult blood (AB) donor. The incidence of some prematurity complications have been demonstrated to increase with AB-RBC tranfusions mainly because of the higher oxygen tissue release, such as retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and necrotizing enterocolitis (NEC). In addition, AB-RBC could contain small amounts of heavy metals that could be toxic for EPI. RBC from umbilical cord blood (UCB-RBC) might be a better alternative as it does not change the hemoglobin profile and consequently might decrease the oxygen toxicity. Several studies have evaluated the safety of UCB-RBC transfusions in preterm infants without finding a higher risk of complications compared with AB-RBC transfusions. A pilot study has been designed to evaluate the safety of UCB-RBC for transfusion in EPI and to determine the feasibility and efficacy of UCB-RBC for transfusion in this group of patients.
研究者
入排标准
入选标准
- •Signed informed consent from parents or legal guardians
- •Preterm infants born earlier than 28 weeks of gestational age.
- •Admission to the neonatal intensive care unit of the participating hospital (Hospital Clínic of Barcelona)
排除标准
- •Previous transfusion
- •Isoimmunization
- •Hydrops fetalis
- •Major congenital malformations
- •Congenital infections
- •Hemoglobinopathies
- •Extreme urgency of blood availability (hypovolemic shock, disseminated intravascular coagulopathy...)
- •Be part of another clinical trial that may interfere with the results
研究组 & 干预措施
Patients exclusively transfused with UCB-RBC
Interventional group infants arm will receive UCB-RBC bag when RBC transfusion is indicated as per standard practice, and when UCB-RBC is available within the first 6 hours of the request.
干预措施: Red blood cell from umbilical cord blood
Patients exclusively transfused with AB-RBC
Standard treatment group infants arm will receive AB-RBC when RBC transfusion is indicated as per standard practice, and compatible UCB-RBC bag is not available.
干预措施: Red blood cell from adult donor
Non transfused patients
Patients with no indications for RBC transfusion. Their clinical management will be the usual in our neonatal unit.
结局指标
主要结局
Number of participants with abnormal vital signs after UCB-RBC transfusion
时间窗: 24 hours after the procedure
The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
Number of participants with abnormal physical examination after red blood cells from umbilical cord blood (UCB-RBC) transfusion
时间窗: 24 hours after the procedure
The number of participants with abnormal physical examination after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in extremely preterm infants (EPI)
Number of participants with altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion
时间窗: 24 hours after the procedure
The number of participants with Altered value of continous monitoring of regional cerebral and somatic oxygen saturation by near-infrared spectroscopy after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
Number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion
时间窗: 24 hours after the procedure
The number of participants with abnormalities in the result of acid-base balance and ionogram after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
Number of participants with morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion
时间窗: 24 hours after the procedure
The number of participants with Morbidities up to 36 weeks of postmenstrual age after UCB-RBC transfusion will be analyzed to evaluated the safety of UCB-RBC in EPI
次要结局
- Number of RBC tranfusions in transfused patients(An average of 3 month (when patients are 36 weeks of postmenstrual age))
- Feasibility of UCB-RBC in EPI(within 6 hours of the request)
- Total volumen of RBC transfused in transfused patients(An average of 3 month (when patients are 36 weeks of postmenstrual age))
- The number of days between two consecutive RBC transfusion in transfused patients(An average of 3 month (when patients are 36 weeks of postmenstrual age))
- Total hemoglobin value (g/dl) in transfused patients(Before transfusion, 24 hours, 1 week, 1 month after transfusion)
- Hematocrit value (%) in transfused patients(Before transfusion, 24 hours, 1 week, 1 month after transfusion)
- Fetal haemoglobin value (%) in transfused patients(Before transfusion, 24 hours, 1 week, 1 month after transfusion)
- Regional cerebral and somatic oxygen saturation (%) value(Before transfusion, 24 hours, 1 week, 1 month after transfusion)