Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Last updated: November 26, 2024
Sponsor: Sohag University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Stress

Williams Syndrome

Vascular Diseases

Treatment

Sildenafil Citrate

Magnesium sulfate

Isotonic saline

Clinical Study ID

NCT04898114
Neb-Mag-2
  • Ages 6-72
  • All Genders

Study 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 persistent pulmonary hypertension on mechanical ventilation.

Eligibility Criteria

Inclusion

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

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 lunghypoplasia).

  • Prior need for cardiopulmonary resuscitation.

  • Mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusionsand vasoactive inotropes.

  • Impaired kidney function.

  • Prior administration of pulmonary vasodilators.

  • Gastrointestinal intolerance or bleeding

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Sildenafil Citrate
Phase: 1/2
Study Start date:
June 02, 2021
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • Neonatal Intensive Care Unit, Sohag University Hospital

    Sohag, 82524
    Egypt

    Active - Recruiting

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