Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367881
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-07
Brief Title:
Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Assessment Of Dose-Dependent Immunomodulatory Effect Of Intratracheal Alveofact With Or Without Local Steroids In Respiratory Distress Syndrome Of Preterm Neonates
Status:
RECRUITING
Status Verified Date:
2024-04
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:
An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide
Detailed Description:
Neonatal respiratory distress syndrome RDS is caused by lung immaturity and surfactant deficiency in preterm newborns and is an important cause of morbidity and mortality
Surfactant therapy plays an essential role in the management of RDS as it reduces lung injury and improves survival While surfactant alone is very effective some studies showed that its combination with budesonide significantly reduces BPD and inflammatory markers
Neutrophils extracellular traps NETs are a defense mechanism where neutrophils are the reaction to microbial infection and cast a net-like structure NETs are composed of chromatin decondensed and some 30 enzymes and peptides Many components such as Neutrophil elastase NE and Myeloperoxidase enzyme MPO have antimicrobial but also a cytotoxic property that causes tissue injury The immune regulatory abilities of the pulmonary surfactant are known to alter the function of the adaptive and innate immune cells
So in this study The Investigator will Assess the immunomodulatory effect of low and high doses of Alveofact with or without Budesonide
Surfactant therapy plays an essential role in the management of RDS as it reduces lung injury and improves survival While surfactant alone is very effective some studies showed that its combination with budesonide significantly reduces BPD and inflammatory markers
Neutrophils extracellular traps NETs are a defense mechanism where neutrophils are the reaction to microbial infection and cast a net-like structure NETs are composed of chromatin decondensed and some 30 enzymes and peptides Many components such as Neutrophil elastase NE and Myeloperoxidase enzyme MPO have antimicrobial but also a cytotoxic property that causes tissue injury The immune regulatory abilities of the pulmonary surfactant are known to alter the function of the adaptive and innate immune cells
So in this study The Investigator will Assess the immunomodulatory effect of low and high doses of Alveofact with or without Budesonide
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