Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898114
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2021-05-20
Brief Title:
Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None