Overview

Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Status:
Recruiting
Trial end date:
2023-05-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sohag University
Treatments:
Magnesium Sulfate
Sildenafil Citrate
Criteria
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