Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

NCT04898114 · tracked via the Priya Life Science Egypt tracker

Sponsor

Sohag University

Phase

Phase 1/2

Started

2021-06-02

Last updated

2024-11-27

Condition(s) studied

Persistent Pulmonary Hypertension of Newborn

Investigational drug(s) / intervention(s)

Magnesium sulfate →Sildenafil Citrate →Isotonic saline

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

Sildenafil 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.

Isotonic saline: Nebulized isotonic saline (4 ml) every 15 minutes

Study 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

Sex

ALL

Min age

6 Hours

Max age

72 Hours

Healthy volunteers

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

Primary outcome measure(s)

Change in Oxygenation index (OI) — From baseline to 2, 6, 12, and 24 hours following study drug administration
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).

Trial sites (1)

Facility	City	Region	Status
Neonatal Intensive Care Unit, Sohag University Hospital	Sohag	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04898114 on ClinicalTrials.gov ↗ ← All trials in Egypt