Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Recruiting · NCT04898114 · Interventional (participants receive a specific treatment) · Lead sponsor: Sohag University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
6 Hours to 72 Hours
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Neonatal Intensive Care Unit, Sohag University Hospital - Sohag, Egypt