A Phase 1/2 interventional study of Magnesium sulfate and Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 6 Hours to 72 Hours. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Sohag University · Phase 1/2, Interventional, and Treatment
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.
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's planned enrollment of 40 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
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Exclusion Criteria:
Nebulized magnesium sulfate and oral sildenafil
Drug: Magnesium sulfate · Drug: Sildenafil Citrate
Nebulized placebo (isotonic saline) and oral sildenafil
Drug: Sildenafil Citrate · Other: Isotonic saline
Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes
Also known as: MgSO4
Oral sildenafil citrate at an initial dose of 1 mg/kg, with incremental increases by 0.5 mg/kg every 6 hours till reaching a target dose of 2mg/kg every 6 hours.
Also known as: Viagra
Nebulized isotonic saline (4 ml) every 15 minutes
Also known as: 0.9% NaCl
Change in Oxygenation index (OI)
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).
Time frame: From baseline to 2, 6, 12, and 24 hours following study drug administration
Change in Mean arterial blood pressure (MABP)
Time frame: From baseline to 2, 6, 12, and 24 hours following study drug administration.
Change in Vasoactive Inotropic Score (VIS)
The VIS will be calculated using the following formula: VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 × epinephrine dose (µg/kg/min) + 100 × norepinephrine dose (µg/kg/min) + 10 × milrinone dose (µg/kg/min) + 10,000 × vasopressin dose (U/kg/min).
Time frame: From baseline to 2, 6, 12, and 24 hours following study drug administration.
Change in Pulmonary artery systolic pressure (PASP)
PASP will be estimated by echocardiography using the modified Bernoulli equation: PASP = (TRJV2 × 4) + RAP (TRJV, tricuspid regurgitation jet velocity; RAP, right atrial pressure).
Time frame: From baseline to 24 hours after study drug administration
Change in Serum magnesium level
Time frame: From baseline to 24 hours after study drug administration
Plan to share: Yes — Unidentified individual participant data will be available from the principal investigator upon reasonable request
Supporting information: Study protocol
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Sohag University