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Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

RecruitingPhase 1, Phase 2Ages 6 Hours - 72 HoursAllSohag University
NCT04898114 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Gestational age ≥ 36 weeks * Birth weight between 2.5 and 4 kg. * Post-natal age between 6 and 72 hours. * PPHN confirmed by echocardiography * Oxygenation index (OI) \> 30 on two occasions at least 15 minutes apart * Connected to Mechanical Ventilation Exclusion Criteria: * Failure to obtain informed consent * Newborns to mothers who received magnesium sulfate within 48 hours before labor. * Congenital heart diseases, other than patent ductus arteriosus 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. * Prior administration of pulmonary vasodilators. * Gastrointestinal intolerance or bleeding
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What it tests

  • Magnesium sulfate
  • Sildenafil Citrate
  • Isotonic saline
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Where

1 site
Neonatal Intensive Care Unit, Sohag University Hospital
Sohag, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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