Nebulized magnesium sulfate and sildenafil for treating newborns with severe pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate in treating neonates with severe persistent pulmonary hypertension (PPHN) who are on mechanical ventilation. The research aims to determine if this combination is more effective than sildenafil alone. PPHN is a serious condition that can lead to significant morbidity and mortality, particularly in settings where advanced treatments are not available. The study will involve neonates aged 6 to 72 hours with confirmed PPHN and specific oxygenation index criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Neonatal Intensive Care Unit, Sohag University Hospital
  Sohag, Egypt Recruiting

Study contacts

• Principal investigator: Elsayed Abdelkreem, MD, PhD — Sohag University
• Study coordinator: Elsayed Abdelkreem, MD, PhD
• Email: d.elsayedmohammed@med.sohag.edu.eg
• Phone: 00201114232126

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.