Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Oxygenation index (OI)
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on mechanical ventilation.
详细描述
Persistent pulmonary hypertension of newborn (PPHN) is a serious condition that results from failure of the normal postnatal circulatory transition and is associated with significant mortality and morbidity. Advanced medical treatment, such as inhaled nitric oxide (iNO), high-frequency ventilation (HFV), and extracorporeal membrane oxygenation (ECMO) are commonly not available in developing countries. Intravenous magnesium sulfate has been shown to alleviate pulmonary hypertension but is associated with systemic hypotension and is less effective compared with iNO and sildenafil. Nebulized magnesium sulfate has been reported to be more effective and safer compared with intravenous magnesium sulfate in treating neonates with PPHN on mechanical ventilation. Combined nebulized magnesium and sildenafil has been studied in a small trial on spontaneously breathing neonates with PPHN but not on those connected to mechanical ventilation.
The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe PPHN on mechanical ventilation. We hypothesize that neonates with severe PPHN connected to mechanical ventilation could benefit from taking continuous nebulization of magnesium sulfate combined besides sildenafil.
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)
盲法说明
Each neonate will be assigned a unique identification number. Pharmacy will fill the active and placebo preparations in similar containers with sealed code for identification. Participants' families, treating clinicians, nurses, echocardiographers, and data collectors will be unaware of group assignment and drug/placebo therapy.
入排标准
- 年龄范围
- 6 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥ 36 weeks
- •Birth weight between 2.5 and 4 kg.
- •Post-natal age between 6 and 72 hours.
- •PPHN confirmed by echocardiography
- •Oxygenation index (OI) > 30 on two occasions at least 15 minutes apart
- •Connected to Mechanical Ventilation
排除标准
- •Failure to obtain informed consent
- •Newborns to mothers who received magnesium sulfate within 48 hours before labor.
- •Congenital heart diseases, other than patent ductus arteriosus and foramen ovale.
- •Major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia).
- •Prior need for cardiopulmonary resuscitation.
- •Mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusions and vasoactive inotropes.
- •Impaired kidney function.
- •Prior administration of pulmonary vasodilators.
- •Gastrointestinal intolerance or bleeding
研究组 & 干预措施
NebMag
Nebulized magnesium sulfate and oral sildenafil
干预措施: Magnesium sulfate (Drug)
NebMag
Nebulized magnesium sulfate and oral sildenafil
干预措施: Sildenafil Citrate (Drug)
Control
Nebulized placebo (isotonic saline) and oral sildenafil
干预措施: Sildenafil Citrate (Drug)
Control
Nebulized placebo (isotonic saline) and oral sildenafil
干预措施: Isotonic saline (Other)
结局指标
主要结局
Change in Oxygenation index (OI)
时间窗: From baseline to 2, 6, 12, and 24 hours following study drug administration
OI will be calculated using the following formula: OI = \[(FiO2 × MAP) / PaO2\] (FiO2, fraction of inspired oxygen expressed in %; MAP, mean airway pressure in cmH2O/mmHg; and PaO2, partial pressure of arterial oxygen in mmHg).
次要结局
- Change in Pulmonary artery systolic pressure (PASP)(From baseline to 24 hours after study drug administration)
- Change in Mean arterial blood pressure (MABP)(From baseline to 2, 6, 12, and 24 hours following study drug administration.)
- Change in Vasoactive Inotropic Score (VIS)(From baseline to 2, 6, 12, and 24 hours following study drug administration.)
- Change in Serum magnesium level(From baseline to 24 hours after study drug administration)
研究者
Elsayed Abdelkreem
Lecturer of Pediatrics
Sohag University