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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04898114
Study type Interventional
Source Sohag University
Contact Elsayed Abdelkreem, MD, PhD
Phone 00201114232126
Email d.elsayedmohammed@med.sohag.edu.eg
Status Recruiting
Phase Phase 1/Phase 2
Start date June 2, 2021
Completion date September 1, 2023

See also
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Completed NCT01203423 - Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
Withdrawn NCT01891500 - Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure Phase 4
Recruiting NCT01373749 - Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension N/A
Terminated NCT00443859 - N-Terminal Pro-brain Natriuretic Peptide Hormone and Persistent Pulmonary Hypertension N/A
Completed NCT01757782 - Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns Phase 4