Nebulized magnesium sulfate and sildenafil for treating newborns with severe pulmonary hypertension
Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn
This study is testing if a mix of nebulized magnesium sulfate and sildenafil can help newborns with severe pulmonary hypertension who are on breathing machines feel better compared to just using sildenafil alone.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Hours to 72 Hours |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT04898114 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate in treating neonates with severe persistent pulmonary hypertension (PPHN) who are on mechanical ventilation. The research aims to determine if this combination is more effective than sildenafil alone. PPHN is a serious condition that can lead to significant morbidity and mortality, particularly in settings where advanced treatments are not available. The study will involve neonates aged 6 to 72 hours with confirmed PPHN and specific oxygenation index criteria.
Who should consider this trial
Good fit: Ideal candidates are neonates aged 6 to 72 hours with a gestational age of at least 36 weeks and confirmed PPHN on mechanical ventilation.
Not a fit: Patients with congenital heart diseases, major congenital anomalies, or those who have received magnesium sulfate shortly before labor may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing severe PPHN in newborns.
How similar studies have performed: While similar approaches have been explored, this specific combination of nebulized magnesium sulfate and sildenafil for mechanically ventilated neonates with PPHN has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sohag
- Neonatal Intensive Care Unit, Sohag University Hospital — Sohag, Egypt (Recruiting)
Study contacts
- Principal investigator: Elsayed Abdelkreem, MD, PhD — Sohag University
- Study coordinator: Elsayed Abdelkreem, MD, PhD
- Email: d.elsayedmohammed@med.sohag.edu.eg
- Phone: 00201114232126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.