Status:
RECRUITING
Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Lead Sponsor:
Sohag University
Conditions:
Persistent Pulmonary Hypertension of Newborn
Eligibility:
All Genders
6-72 years
Phase:
PHASE1
PHASE2
Brief 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 persist...
Detailed Description
Persistent pulmonary hypertension of newborn (PPHN) is a serious condition that results from failure of the normal postnatal circulatory transition and is associated with significant mortality and mor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04898114
Start Date
June 2 2021
End Date
June 1 2025
Last Update
November 27 2024
Active Locations (1)
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1
Neonatal Intensive Care Unit, Sohag University Hospital
Sohag, Egypt, 82524