Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn
Who is this study for? Patients with persistent pulmonary hypertension of newborn
What treatments are being studied? Magnesium sulfate+Sildenafil Citrate
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 3 days
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Egypt
Neonatal Intensive Care Unit, Sohag University Hospital
RECRUITING
Sohag
Contact Information
Primary
Elsayed Abdelkreem, MD, PhD
d.elsayedmohammed@med.sohag.edu.eg
00201114232126
Time Frame
Start Date: 2021-06-02
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 40
Treatments
Experimental: NebMag
Nebulized magnesium sulfate and oral sildenafil
Placebo_comparator: Control
Nebulized placebo (isotonic saline) and oral sildenafil
Related Therapeutic Areas
Sponsors
Leads: Sohag University