Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sohag University
• Treatments: Magnesium Sulfate; Sildenafil Citrate

Criteria

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