RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- Failure to obtain willing to sign a consent form
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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
Locations (1)
Neonatal Intensive Care Unit, Sohag University Hospital
Sohag, Egypt