Actively Recruiting
Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Led by Sohag University · Updated on 2024-11-27
40
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age 236 weeks or more
- Birth weight between 2.5 and 4 kilograms
- Post-natal age between 6 and 72 hours
- Diagnosis of persistent pulmonary hypertension of the newborn confirmed by echocardiography
- Oxygenation index greater than 30 on two occasions at least 15 minutes apart
- Currently connected to mechanical ventilation
You will not qualify if you...
- Inability to obtain informed consent
- Newborns whose mothers received magnesium sulfate within 48 hours before labor
- Presence of congenital heart diseases other than patent ductus arteriosus and foramen ovale
- Major congenital anomalies, including congenital diaphragmatic hernia and lung hypoplasia
- Previous need for cardiopulmonary resuscitation
- Mean arterial blood pressure below 35 mmHg despite therapy
- Impaired kidney function
- Prior use of pulmonary vasodilators
- Gastrointestinal intolerance or bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Neonatal Intensive Care Unit, Sohag University Hospital
Sohag, Egypt, 82524
Actively Recruiting
Research Team
E
Elsayed Abdelkreem, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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