Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Oxygenation index (OI)
研究概览
简要总结
The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN.
详细描述
The effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30 minutes, followed by 50 mg/kg/hour) in treating mechanically ventilated neonates with severe persistent pulmonary hypertension of the newborn.
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, Outcomes Assessor)
盲法说明
Each neonate was assigned a unique identification number. Pharmacy filled the active and placebo preparations in similar containers with sealed code for identification. Participants' families, treating clinicians, nurses, echocardiographers, and data collectors were 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
- •Newborns with PPHN fulfilling the following:
- •born at ≥ 37 weeks gestational age.
- •birth weight between 2.5 and 4 kg.
- •post-natal age between 6 and 72 hours.
- •connected to mechanical ventilation with an oxygenation index (OI) > 30 on two occasions at least 15 minutes apart.
- •documented PPHN confirmed by echocardiography.
排除标准
- •failure to obtain informed consent.
- •infants of mothers who received magnesium sulfate within 48 hours before labor.
- •congenital heart diseases (other than PDA 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 inotrpic support.
- •impaired kidney function.
- •prior administration of pulmonary vasodilators.
研究组 & 干预措施
NebMag
Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo
干预措施: Nebulized Magnesium Sulfate (Drug)
IVMag
Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo
干预措施: Intravenous Magnesium Sulfate (Drug)
结局指标
主要结局
Oxygenation index (OI)
时间窗: At baseline to 2, 6, 12, and 24 hours following study drug administration.
Change in oxygenation index (OI) calculated by the classic formula: OI = \[(FiO2 \* MAP) / PaO2\] FiO2 expressed in %; MAP in cmH2O/mmHg; and PaO2 in mmHg
次要结局
- Mean arterial blood pressure (MABP)(At baseline to 2, 6, 12, and 24 hours following study drug administration.)
- Serum magnesium level(At baseline to 12 hours after study drug adminstration)
- Vasoactive Inotropic Score (VIS)(At baseline to 2, 6, 12, and 24 hours following study drug administration)
研究者
Elsayed Abdelkreem
Lecturer of Pediatrics
Sohag University