NCT04328636

Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 6 Hours – 72 Hours
• Healthy volunteers: Not accepted

Summary

The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN.

Detailed description

The effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30 minutes, followed by 50 mg/kg/hour) in treating mechanically ventilated neonates with severe persistent pulmonary hypertension of the newborn.

Conditions

• Persistent Fetal Circulation
• Persistent Pulmonary Hypertension of the Newborn
• PPHN

Interventions

Type	Name	Description
DRUG	Nebulized Magnesium Sulfate	Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes
DRUG	Intravenous Magnesium Sulfate	Intravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour

Timeline

• Start date: 2017-11-01
• Primary completion: 2020-07-01
• Completion: 2020-08-01
• First posted: 2020-03-31
• Last updated: 2020-08-18

Locations

1 site across 1 country: Egypt