The Effect Of Nebulizied Nitroglycerin As An Adjuvant Drug In Management Of Persistent Pulmonary Hypertension Of Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Right ventricular (RV) function in ml/kg/min
研究概览
简要总结
This aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting) in patients with PPHN.
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
- 1 Hour 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants ≤72 hours' old, ≥37 weeks of gestation, ≥50% FiO2 need despite lung recruitment, abnormal oxygen saturation index or echocardiographic signs of PPHN will be enrolled in the trial.
排除标准
- •• Diagnosis of PPHN discovered after more than 72 hours.
- •Failure of used medications and need to administrate milrinone
研究组 & 干预措施
Group I (nebulized nitroglycerine)
Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN
干预措施: Nebulized nitroglycerine as adjunctive therapy (Drug)
Group II (conentional treatment group)
Patients with PPHN and will be treated with conventional regimen for PPHN
干预措施: conventional therapy for PPHN (Drug)
结局指标
主要结局
Right ventricular (RV) function in ml/kg/min
时间窗: first 7 days of life
• RV output and stroke distance in main pulmonary artery: * CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus - mid-systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). 12. ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). * Output (L/min.) COP = SV x HR.
Estimation of Pulmonary artery pressure (PAP)
时间窗: first 7 days of life
Systolic pulmonary artery pressure (SPAP) can be estimated by measuring the peak velocity of tricuspid valve regurgitation with the use of the modified Bernoulli's equation. * The estimation of SPAP by measuring TR is reliable and often equivalent to pressures measured in the catheter lab while using continuous wave Doppler. However, the accuracy depends on the quality of the acquired TR jet. An optimal quality TR jet shows a well demarcated envelope. * Right atrial pressure (RAP) is usually not measured, and a value of 3- 5 mmHg is generally assumed.
Left ventricular (LV)function in ml/kg/min
时间窗: first 7 days of life
LV output and stroke distance in ascending aorta: * CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius)2. ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5-chamber view). * SV (ml/beat) (Stroke Volume = CSA x VTI). * Output (L/min.) COP = SV x HR.
次要结局
未报告次要终点
研究者
Marwa Mohamed Farag
Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine
Alexandria University