RecruitingPhase 1Phase 2NCT04898114

Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn


Sponsor

Sohag University

Enrollment

40 participants

Start Date

Jun 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 HoursMax Age: 72 Hours

Plain Language Summary

Simplified for easier understanding

This trial is testing two treatments — nebulized magnesium sulfate (inhaled through a breathing mask) and sildenafil (commonly known as Viagra, but used here to relax blood vessels in the lungs) — for newborns with persistent pulmonary hypertension (PPHN), a serious condition where blood pressure in the lungs is dangerously high. **You may be eligible if...** - Your baby is at least 36 weeks gestational age - Your baby weighs between 2.5 and 4 kg at birth - Your baby is between 6 and 72 hours old - Your baby has been diagnosed with PPHN confirmed by heart ultrasound (echocardiography) - Your baby has a high oxygen index (OI >30 on two readings) and is on a ventilator **You may NOT be eligible if...** - The mother received magnesium sulfate within 48 hours before delivery - Your baby has a congenital heart defect (other than patent ductus arteriosus or patent foramen ovale) - Your baby has a major birth defect (like a diaphragmatic hernia) - Your baby has needed resuscitation at birth - Your baby has very low blood pressure not responding to medications - Your baby has kidney problems or GI bleeding - Your baby has previously received drugs to lower lung blood pressure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMagnesium sulfate

Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes

DRUGSildenafil Citrate

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.

OTHERIsotonic saline

Nebulized isotonic saline (4 ml) every 15 minutes


Locations(1)

Neonatal Intensive Care Unit, Sohag University Hospital

Sohag, Egypt

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NCT04898114


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