Trial on Treatment With Inhaled Furosemide of Preterm and Term Neonates With Transient Tachypnoea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction of the Silverman-Score
研究概览
简要总结
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with Transient Tachypnoea.
详细描述
In this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient Tachypnoea. Patients received nebulised Furosemide iv solution 1 mg/kg or nebulised 0,9% saline (4x/d) under blind conditions in random order so long as need a CPAP-treatment but max. 3 days. 20 Patient will be treating.
The benefit will be measured as reduction of dyspnea, respiratory rate, oxygen demand and time on CPAP.
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
- 6 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with 35+0-39+0 GA on the first day of life with the clinical diagnosis of Transient Tachypnoea
- •The need for CPAP >6 h to obtain the oxygen saturation >92%
- •Written informed consent of parent/guardian
排除标准
- •Systemic infection
- •Intubation and mechanical ventilation before Inclusion in the trail
- •Malformation and any other several disease with disturb of respiratory
- •Subjects participating in other clinical trials
研究组 & 干预措施
Furosemide
1 mg/kg/Ed
干预措施: Furosemide (Drug)
Saline 0,9%
1ml/kg/Ed
干预措施: Saline 0,9% (Drug)
结局指标
主要结局
Reduction of the Silverman-Score
时间窗: 0-72 h or up to end of CPAP after start of the study
The primary endpoint of the study is the reduction of the Silverman score as an indicator of respiratory distress of the infant. Silverman Score is the standard score to describe the degree of respiratory distress of neonate.
次要结局
- blood electrolytes (Na+, K+, Ca++, HCO3-, Cl-)(0-72 h after start of the study)
- CPAP-time(0-72 h or up to end of CPAP after start of the study)
- blood gas (pH, pCO2,pO2)(0-72 h after start of the study)
- body weight(1-3 day of life)
- Oxygen supplementation(0-72 h or up to end of CPAP after start of the study)
- A need for secondary intubation and mechanical ventilation(1-3 day of life)
研究者
Patrizia Nitsch-Felsecker
Dr. med.
University of Cologne