Comparative Study Between Nebuliezed and Intravenous Magnesium Sulfate for Treatment of Persistant Pulmonary Hypertension in Neonates
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean Airway Pressure (cm H2O)
研究概览
简要总结
we conducted this study to compare between effect of nebulized and intravenous magnesium sulfate (MgSO₄) for better treatment of persistent pulmonary hypertension of neonates with less side effects.
详细描述
Persistent pulmonary hypertension of the newborn (PPHN) is a serious syndrome characterized by sustained fetal elevation of pulmonary vascular resistance (PVR) at birth. The syndrome is seen in two of 1000 live-born infants and is associated with anormal or low systemic vascular resistance. Pulmonary hypertension is defined as a mean pulmonary artery pressure greater than 25 mmHg at rest and > 30 mmHg during exercise. PPHN-targeted therapy is used for infants with PPHN who fail to respond to general cardiopulmonary supportive care. Oxygen and inhaled Nitric Oxide (iNO) are the only well-studied pulmonary vasodilators in neonates with PPHN. Magnesium is a potent vasodilator and hence has the potential to reduce the high pulmonary arterial pressures as it's able to dilate constricted muscles in the pulmonary arteries. However, its action is not specific and when given via an intravenous infusion, it will act on other muscles in the body including other arteries. Excessive magnesium causes hypotonia, hypotension, and cardiorespiratory failure. However, no studies have demonstrated long-term benefit. Delivering magnesium sulfate by nebulization may enhance effectiveness and minimizes systemic adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with documented persistent pulmonary hypertension as confirmed by echocardiography.
- •Neonates born at ≥ 35 wk. gestation with a birth weight of 2.5-4 kg
- •Neonates have to be connected to mechanical ventilation with an oxygenation index (OI) >30 on two occasions at least 15 min apart.
- •The echocardiogram had to show a predominant right-to-left or bidirectional shunt (through ductus arteriosus and/or foramen oval) and/or tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of the systemic systolic blood pressure.
排除标准
- •Infants of parents who refuse to give informed consent.
- •Infants of mothers who receive magnesium sulfate within 48 h before labor.
- •Congenital heart diseases other than patent ductus arteriosus (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 vasoactive inotropes.
- •Impaired kidney function; and prior administration of pulmonary vasodilators or prior administration of surfactant.
研究组 & 干预措施
Nebulized magnesium (NebMag) group 1
NebMag group (n=20) was administered nebulized isotonic magnesium (64 mg/mL). For nebulization, an isotonic MgSO₄ solution (64 mg/mL) was formulated by diluting a 10% intravenous preparation of MgSO₄ heptahydrate with sterile distilled water. 4 mL aliquots of the isotonic MgSO₄ solution (containing 256 mg of MgSO₄) were administered every 15 minutes through the jet nebulizer connected to the ventilator during the 24 hour study period.
干预措施: Inhalational magnesium sulfate (Drug)
Intravenous magnesium (IVMag) group 2
IVMag group (n=20) received intravenous magnesium. For intravenous administration, a 10% MgSO₄ solution was prepared by diluting a 50% intravenous formulation of MgSO₄ heptahydrate with 5% glucose and administrated in a loading dose of 2 mL/kg over 30 minutes (equivalent to 200 mg/kg of MgSO₄), followed by a continuous infusion at a rate of 0.5 mL/kg/h (equivalent to 50 mg/kg/h of MgSO₄) over the 24 hour study period.
干预措施: IV Magnesium Sulfate (Drug)
结局指标
主要结局
Mean Airway Pressure (cm H2O)
时间窗: from baseline to 12 and 24 hours after administering the study drug
Fraction of Inspired Oxygen (FiO2) (%)
时间窗: from baseline to 12 and 24 hours after administering the study drug
PaO2 (mmHg)
时间窗: from baseline to 6, 12 and 24 hours after administering the study drug
kPa x 7.5 converts to the equivalent PaO2 in mmHg
Tracking Changes in the Oxygenation Index (OI)
时间窗: from baseline to 12 and 24 hours after administering the study drug
OI evaluates both oxygenation and ventilatory support, aiding decisions on Extracorporeal Membrane Oxygenation (ECMO) necessity in newborns with PPHN. OI calculated as (Mean Airway Pressure (cm H2O) x Fraction of Inspired Oxygen (%) x 100) ÷ (PaO2 (kPa) x 7.5). OI is routinely used as an indicator of severity of hypoxemic respiratory failure (HRF) in neonates, with an arbitrary cutoff of 15 or less for mild HRF, between 16 and 25 for moderate HRF, between 26 and 40 for severe HRF, and more than 40 for very severe HRF
次要结局
- the Variations in Mean Arterial Blood Pressure (MABP)(at 0, 12, and 24 hours post administration of the study drug relative to baseline)
- the Alterations in Serum Magnesium Levels (mmol/L)(from baseline to 12 hours following the administration of the study drug.)
研究者
Heba Morsy Saad El Din El Ganady
Principal investigator
Benha University