Trials / Recruiting
RecruitingNCT06367881
Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS
Assessment Of Dose-Dependent Immunomodulatory Effect Of Intratracheal Alveofact With Or Without Local Steroids In Respiratory Distress Syndrome Of Preterm Neonates
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Ain Shams University · Academic / Other
- Sex
- All
- Age
- 1 Day – 2 Days
- Healthy volunteers
- Not accepted
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.
Conditions
- Neonatal Respiratory Distress Syndrome
- Inflammatory Response
- Premature Lungs
- Neutrophil Extracellular Trap Formation
- Preterm Birth
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alveofact | Intratracheal High-dose Alveofact versus Low-dose Alveofact with or without Budesonide |
| DRUG | Budesonide | Budesonide |
Timeline
- Start date
- 2022-08-18
- Primary completion
- 2024-07-01
- Completion
- 2024-10-01
- First posted
- 2024-04-16
- Last updated
- 2024-04-16
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT06367881. Inclusion in this directory is not an endorsement.