NCT04898114RecruitingPhase 1/2
Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 20 May 2021
- Start date
- Jun 2021
- Primary completion date
- Apr 2025
- Lead sponsor
- Sohag University
- NCT number
- NCT04898114
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From Jun 2021 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior need for cardiopulmonary resuscitation.
- Mean arterial blood pressure (MABP) \< 35 mmHg despite therapy with volume infusions and vasoactive inotropes.
- Prior administration of pulmonary vasodilators.
Other illness
- Failure to obtain informed consent
- Congenital heart diseases, other than patent ductus arteriosus and foramen ovale.
- Gastrointestinal intolerance or bleeding
Lab values
- Newborns to mothers who received magnesium sulfate within 48 hours before labor.
Other
- Major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia).
- Impaired kidney function.
Who the study is looking for
- 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
Age in the registry: 6 hours to 72 hours · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neonatal Intensive Care Unit, Sohag University Hospital Coordinator of this site? Confirm its status | Sohag | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.