Pediatrics Department, Faculty of Medicine, Benha University.
Benha, Egypt., Egypt
NCT Number: NCT06603766
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.
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All sexes
Interventional
Phase 2 / Phase 3
Benha, Egypt., Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: IV MgSO4
It gives us the same mechanism of action as IV MgSO4 with less side effects.
Other names: Inhalational MgSO4
Time frame: from baseline to 12 and 24 hours after administering the study drug
Time frame: from baseline to 12 and 24 hours after administering the study drug
Time frame: from baseline to 6, 12 and 24 hours after administering the study drug
kPa x 7.5 converts to the equivalent PaO2 in mmHg
Time frame: 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
Time frame: at 0, 12, and 24 hours post administration of the study drug relative to baseline
Both systolic and diastolic pressure are used to calculate MABP.
Time frame: from baseline to 12 hours following the administration of the study drug.
Benha University
Other
Comparative Study Between Nebuliezed and Intravenous Magnesium Sulfate for Treatment of Persistant Pulmonary Hypertension in Neonates
Acronym: PPHN
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