A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
试验速览
- 阶段
- 3 期
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Cardiac chamber volume loading.
研究概览
简要总结
The purpose of this study is to investigate the effects of intravenous furosemide on cardio-respiratory performance in neonates receiving a packed red blood cell (PRBC) transfusion who are considered at high risk of volume overload.
详细描述
Red cell transfusion is a very common practice in neonates, particularly in preterm infants. It has been estimated that approximately 300,000 neonates undergo transfusions annually. The decision to administer a blood transfusion to a sick anemic neonate is made after consideration of multiple clinical factors, including: poor weight gain, oxygenation failure, and recurrent apnea and bradycardia. These decisions are also influenced by physician preferences. For many years, furosemide has been used routinely by physicians during and after blood transfusions in neonates and other age groups. The rationale behind this common practice is to reduce the vascular overload that may be imposed by the additional blood volume delivered during transfusion. This belief, however, lacks the support of scientific clinical evaluation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Week 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 44 weeks corrected gestational age
- •Receiving a red cell transfusion
- •Satisfy one of the following criteria:
- •Echocardiographic evidence of a hemodynamically significant ductus arteriosus (HSDA) defined by a transductal diameter >1.5 mm and unrestrictive systemic-pulmonary trans-ductal flow
- •Clinical evidence of significant lung disease defined by a need for respiratory support (assisted ventilation or nasal CPAP) and oxygen supplementation after 28 days of age
排除标准
- •Infants with multiple congenital anomalies or renal insufficiency
- •Infants with hypotension, hypertension, or on any cardiac medication
- •Infants with sepsis causing compromised clinical condition such as disseminated intravascular coagulopathy
- •Infants with contra-indications to diuretic therapy, such as significant electrolyte imbalance, or endocrine disease
研究组 & 干预措施
1
Furosemide
干预措施: Furosemide (Drug)
2
干预措施: Saline (Drug)
结局指标
主要结局
Cardiac chamber volume loading.
时间窗: 4 hours after drug administration and 24 hours post recruitment
次要结局
- Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement).(4 hours after drug administration and 24 hours post recruitment)
- Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).(4 hours after drug administration and 24 hours post recruitment)
- Changes in electrolyte balance, body weight and urine output.(4 hours after drug administration and 24 hours post recruitment)