Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Sohag University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Persistent Pulmonary Hypertension of Newborn

Treatments: Drug: Magnesium sulfate; Other: Isotonic saline; Drug: Sildenafil Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04898114

Neb-Mag-2

Details and patient eligibility

About

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.

Full 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 morbidity. Advanced medical treatment, such as inhaled nitric oxide (iNO), high-frequency ventilation (HFV), and extracorporeal membrane oxygenation (ECMO) are commonly not available in developing countries. Intravenous magnesium sulfate has been shown to alleviate pulmonary hypertension but is associated with systemic hypotension and is less effective compared with iNO and sildenafil. Nebulized magnesium sulfate has been reported to be more effective and safer compared with intravenous magnesium sulfate in treating neonates with PPHN on mechanical ventilation. Combined nebulized magnesium and sildenafil has been studied in a small trial on spontaneously breathing neonates with PPHN but not on those connected to mechanical ventilation.

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 PPHN on mechanical ventilation. We hypothesize that neonates with severe PPHN connected to mechanical ventilation could benefit from taking continuous nebulization of magnesium sulfate combined besides sildenafil.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

NebMag

Experimental group

Description:

Nebulized magnesium sulfate and oral sildenafil

Treatment:

Drug: Sildenafil Citrate

Drug: Magnesium sulfate

Control

Placebo Comparator group

Description:

Nebulized placebo (isotonic saline) and oral sildenafil

Treatment:

Drug: Sildenafil Citrate

Other: Isotonic saline