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Taking people in EgyptPhase 1/2

Tests nebulized magnesium with sildenafil for newborn lung blood pressure

Tests inhaled magnesium plus sildenafil in newborns with severe persistent pulmonary hypertension.

Plain-language title generated from the registry record
Registry title: Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Key facts

Where
Sohag, EgyptSee the site
Phase
Phase 1/2

Where in Egypt

  • Neonatal Intensive Care Unit, Sohag University HospitalSohag, EgyptTaking people

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Trial details

Who runs it
Sohag University
Trial code
NCT04898114
Record updated
27 November 2024
Original description
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.Read full original descriptionShow less

Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in 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.

Inclusion: 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: Prior need for cardiopulmonary resuscitation; Mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusions and vasoactive inotropes; Prior administration of pulmonary vasodilators; Failure to obtain informed consent; Congenital heart diseases, other than patent ductus arteriosus and foramen ovale; Gastrointestinal intolerance or bleeding; Newborns to mothers who received magnesium sulfate within 48 hours before labor; Major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia); Impaired kidney function.

ClinicalTrials.gov NCT04898114