Recruiting
Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
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.
ClinicalTrials.gov IDNCT04898114
PhasePHASE1, PHASE2
Enrollment40
SponsorSohag University
Age6 Hours – 72 Hours
SexALL
Conditions studied
Persistent Pulmonary Hypertension of Newborn
About this study
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.
Interventions
- Drug: Magnesium sulfate — Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes
- Drug: Sildenafil Citrate — Oral sildenafil citrate at an initial dose of 1 mg/kg, with incremental increases by 0.5 mg/kg every 6 hours till reaching a target dose of 2mg/kg every 6 hours.
- Other: Isotonic saline — Nebulized isotonic saline (4 ml) every 15 minutes
Primary outcomes
- Change in Oxygenation index (OI) (From baseline to 2, 6, 12, and 24 hours following study drug administration)
Eligibility information
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
Study locations
- Neonatal Intensive Care Unit, Sohag University Hospital, Sohag, 82524 Egypt
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.