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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
MgSO₄'s mechanism in PPHN includes activating cellular processes, modulating membrane excitability, and acting as a physiological calcium antagonist. It exerts sedative, muscle relaxant, and bronchodilatory properties, while concurrently inducing a state of alkalosis.
It gives us the same mechanism of action as IV MgSO4 with less side effects.
Pediatrics Department, Faculty of Medicine, Benha University.
Benha, Egypt., Egypt
Mean Airway Pressure (cm H2O)
Time frame: from baseline to 12 and 24 hours after administering the study drug
Fraction of Inspired Oxygen (FiO2) (%)
Time frame: from baseline to 12 and 24 hours after administering the study drug
PaO2 (mmHg)
kPa x 7.5 converts to the equivalent PaO2 in mmHg
Time frame: from baseline to 6, 12 and 24 hours after administering the study drug
Tracking Changes in the Oxygenation Index (OI)
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
Time frame: from baseline to 12 and 24 hours after administering the study drug
the Variations in Mean Arterial Blood Pressure (MABP)
Both systolic and diastolic pressure are used to calculate MABP.
Time frame: at 0, 12, and 24 hours post administration of the study drug relative to baseline
the Alterations in Serum Magnesium Levels (mmol/L)
Time frame: from baseline to 12 hours following the administration of the study drug.
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