Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04064684
Status:
TERMINATED
Last Update Posted:
2022-07-13
First Post:
2019-08-16
Brief Title:
Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome PARDS a Randomized Pilot Trial
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment difficulties after the start of the COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free daysto improve the oxygenation index OI or oxygenation saturation index OSI in patients receiving inhaled steroids and to show the relevance and feasibility of a larger study by assessing the hypothesis in a small cohort of patients Patient will be treated for a maximum of 10 days Secondary objectives are to reduce the length of stay LOS in the pediatric intensive care unit PICU and hospital admissions to show less inflammation in the patients receiving inhaled steroids by measuring inflammatory markers from tracheal aspirates like Interleukin IL6 IL8 tumor necrosis factor TNF α matrix metalloproteinase8 MMP8 and matrix metalloproteinase9 MMP9 Lastly to show that inhaled steroids can improve residual lung disease evaluated by Pulmonary Function Test PFTs and Impulse Oscillometry IOS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KL2TR003168 | NIH | None | httpsreporternihgovquickSearchKL2TR003168 |